Links to 1006 Entry-Level Biotechnology & Life Science Jobs

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.

Applies knowledge of technical principles and Edwards systems/procedures to tptimize manufacturing processes. Responsibilities include: Improve manufacturing processes using engineering methods for concinous process improvement. Develop basic experiements and tests to qualify and validate manfactruing process, etc.

Supports all phases of clinical study activities including: TMF review, assist with filing and archiving project documentation in theTMF within a 20 day timeframe. Assist with creating, updating and maintaining project trackers in EPIC. Provides support for document preparation. Attend internal study team meetings, and prepare and distribute study team agendas and minutes. etc.

Multiple positions. Position titles include but are not limited to Plant Engineer, Process Engineer, Project Engineer, Development Engineer, Automation and/or Control Engineer, and are available in manufacturing and development areas supporting: Bulk processing (Animal health products), facilities/utilities engineering, process development.

The successful candidate will be responsible for developing and performing cell-based assays within the Immunology team achieving common team goals. Responsibilities include: Perform ex-vivo and in-vitro cellular assays with an emphasis on flow cytometry and immuno-assays including ELISA and MSD. Analyze and interpret data and generate high-quality summary reports in a timely manner, and present findings in the inter and intra departmental group meetings. Document experimental data and results and maintain a current and accurate electronic notebook (ELN)

The Associate I (ASI) will perform safety testing required to manufacture clinical and commercial products. The ASI is required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Additionally, they are required to maintain a thorough understanding of BioReliance services, technical principles and applications.

Provide Food Safety and Quality systems support for the Flavors and Fragrances product line while ensuring adherence to GMPs and working to improve the Supplier Quality Management program. The Flavors and Fragrances facility is FSSC 22000 certified as well as ISO900. Responsibilities include: ensuring compliance with FSSC 2200 and ISO9001, support customer complaint management, etc.

We have an opening for an Associate Scientist to join the Immuno-Oncology platform at EMD Serono, Billerica, MA. The successful candidate will support the discovery of novel cancer immunotherapies. In this role, the candidate is expected to develop and conduct cellular immune assays to characterize small molecules or biologics that modulate the tumor immune environment and enhance the anti-tumor immune response. The Associate Scientist will also develop, evaluate and implement well-controlled in vitro experiments to interrogate target biology, and generate proof of concept data supporting target Go/No Go decisions.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities. Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures. etc.

The Analyst I position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Equipment, Utilities, and Software Validation. Responsibilities include: Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc. Write summary reports, following good documentation practices. Use Kaye Validator, DataTrace dataloggers, and/or Veriteq dataloggers to perform mapping studies. Analyze statistical data to verify acceptable criteria. etc.

The right candidate must be organized and calm under pressure. Excellent communication skills are essential for this role for external interactions. This position requires a professional demeanor and a high level of discretion in regards to handling of confidential company information. Must enjoy a “start-up” atmosphere and be flexible, show initiative, good judgment and be willing to take on additional tasks and responsibilities as needed to achieve goals and deliverables. Must have strong knowledge of Microsoft Office (Outlook, Excel, Word, PowerPoint)

The Manufacturing Associate I – Fermentation works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS). This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.

Under general supervision performs repetitive inspection tasks on assembled products using Standard Work Instructions and Device History Records (DHRs) while maintaining training certifications. Will work from written and/or verbal instructions while maintaining pace with production requirements. Will interact with internal customers to help resolve, inspection and/or components issues. etc.

The Surgical Instrument Repair Excellence (SIRE) Apprenticeship Program is a two to three-year process that is monitored by the Department of Labor (DOL). The first 4 – 6 months of initial training will be based out of the Houston Training Center (HTC). After completion of the training at HTC you will be required to spend the remainder of the introductory 6 months with established field personnel at their home sites. Learn and become proficient in all aspects of handheld stainless steel instrument sharpening, repair and maintenance (Maintain an average score of 80% on all written and technical assessments).

As an Advanced Quality Engineer, you will support the development of one or more products from concept generation through production, having the unique opportunity to realize the entire product lifecycle. Specifically, you will: Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design. Lead the development of a safety risk management strategy including implementation of risk controls. etc.

Maintenance Technicians are responsible for general repairs and maintenance on buildings, structures and equipment. Maintenance Technicians are generally tasked with day-to-day upkeep of facility equipment that provides vital resources for animal breeding. Performs electrical, electronic, mechanical, hydraulic, and pneumatic maintenance and repair of machinery, equipment, and HVAC system. Performs diagnosing malfunctions in machinery and equipment. Performs dismantling, assembling, and installing industrial machinery. etc.

The technologist will perform qualitiative and quantitative tests and examinations using various analyzers and/or manual methods. Assist in peforming established quality assurance procedures (quality control testing, instrument function checks and calibrations). Mainatains appropriate documentation and reports irregularities.

Conduct analytical runs for R&D purposes using a set of analytical techniques such as HPLC, UPLC, GC, including writing related protocols and reports. Develop, evaluate, validate analytical methods for raw materials and finished products. Support the transfer of developed and qualified assays to relevant clients. Provide support, as related to analytical, plant trouble shooting/investigations and product regulatory submission. Provide full analytical development support in accordance with cGMP/GLP practices to product development programs within strict timelines to successfully meet internal and client program milestones. Support the AR&D related activities for filing of new ANDA. Support the generation of pharmaceutical development reports and related documentation.

Duties include: deliver customer service by providing support using ERT's products. Work and collaborate with project teams in development and delivery of ERT products. Etc.

Duties as an associate scientist include: performs lab work including preparing buffers/reagents/media. Maintain cell cultures in BSL2 lab. Conducts production assays in ADMET, ion channel, immunosignaling, OncoPanel, etc.

Carries out routine experiments and procedures in accordance with all applicable regulatory (e.g. DEA, EPA, FDA, FIFRA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs). Assist/run toxicology studies, including preparing test solutions and daily maintenance of test systems. Feed, water, and examine animals for signs of illness, disease, or injury sustained in the laboratory. Performs analysis, first level, and peer review of data for accuracy and completeness.

Responsibilities include: Develop, qualify and validate analytical test methods for drug products, intermediates and excipients. Design and execute analytical development studies. Write protocols and repors. Maintain and write SOPs. etc.

Responsibilities include: Monitor the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and all applicable regulatory requirements. Conduct visits to assess the qualification of potential investigative sites, initiate sites, instruct site personnel on the proper conduct of studies and use of Electronic Data Capture (EDC) system, review and ensure accuracy of data collected, and terminate studies

Primary role is to perform all forms assembly activities including equipment setup and tear down where required as well as in-process verifications. In addition, this position includes several cross-functional responsibilities comprising Shipping, Receiving, Job Picking, Warehousing and Plant Cleaning and some Maintenance activities. This position also has responsibilities associated with Servicing returned products (disassembly and reassembly, diagnosis and report writing).

The Reagent Manufacturing Associate is a member of our Proteomics Reagent Operations team. The scientist will be accountable for QC testing of raw materials, in-process materials and finished goods for release. This individual will also be a subject matter expert in the development and testing of new QC procedures.

The Product Development Scientist will play an active role in developing high-quality Fluidigm reagents. Responsibilities include: write application, product or system validation test plans. Work with product managers and product applications group. Ensure all valudation tests are in concordance with customer and product requirements. etc.

Basic Duties and Responsibilities: Assisting in clinical medical physics coverage, as well as supporting the commissioning team's project

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also perform HEPA filter integrity/velocity testing and critical area (class 100) airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsibilities include: hand assembly manufactured components, complete required documentation for work performance, quality inspect work performed. etc.

Responsibilities include: Assist with all aspects of EHS, including applicable OSHA regulations, environmental record keeping, safety audits, and accident investigations. Ensure the Emergency Response Plan remains current with regulatory requirements and site needs, assist with the readiness of FDBT personnel and facilities to respond to emergencies. Conduct environmental and safety audits and inspections; assist EHS Management with reporting to Senior Leadership.

Responsibilities include: Construction of gene libraries and expression vectors. Characterization of gene variants. Primer design. DNA isolation. DNA sequencing. Cloning of genes and genetic pathways. Work with project teams to provide support and assistance to all phases of directed evolution projects, contribute to team presentations and written reports.

Codiak is seeking a qualified associate scientist to join our growing Research organization and contribute to the development of the company’s innovative exosome engineering platform. Responsibilities include: Produce, purify, and characterize engineered exosomes from conditioned cell culture medium; Execute biochemical and cell-based assays to validate target and pathway engagement of therapeutic candidates; Express and purify recombinant proteins, including antibodies, enzymes, and fusion proteins, at the milligram scale to support assay development for ongoing projects;etc.

As a member of the engineering services team, the Electrical Engineer I will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Electrical Engineering Manager, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies, and applying engineering design principles and practices.

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. General lab duties, such as restocking supplies and maintaining inventory.

The Design Engineer I will be responsible for design and development of new orthopedic implants and related instrumentation systems and the creation of documentation in support of quality systems and concept to medical device which achieve quality, cost and time to market requirements. Understand the objectives, responsibilities, and mission of the Engineering department and works towards those goals. Develop protocols for design verification and validation (V&V), including outside test and research labs. Complete corresponding test reports. Communicate with customers, sales, marketing and independent entities to gain knowledge of product design requirements.

Supports management, sales, marketing, contracts, and other administrative areas by providing timely and accurate financial projections, price quotations, contracts, and profit analyses. Performs financial analyses, including forecasts, projections, and historical assessments. Produces quotes for capital and/or disposables not covered by existing contracts. Facilitates communication among management, sales, and contracts staffs regarding contract and price.

The Quality Engineer New Product Development (NPD) is responsible for supporting all quality engineering activities to support the new product life cycle, from concept through commercialization and sustaining changes, as part of a cross-functional development team. Serves as the key resource for ensuring compliance to ISO, MDD and QSR requirements for Medical Devices. Takes the lead with quality initiatives with inter-organizational impact following QSR, ConMed Policies and standards. Works under direction from Quality Management.

The Mechanical Engineer will work with a cross-functional teams on new product development and sustaining engineering activities. Support the development of new and existing product specifications and requirements based on design input requirements, in collaboration with the project engineer. Supports the writing of technical reports, risk management documents, VOC summaries, test protocols and design input and output documents. Create detailed 3D CAD models and drawings of mechanical and electrical parts and assemblies

The Quality Control Microbiology Assistant at Cook MyoSite will assist GMP testing and perform environmental monitoring activities to support lot release and in-process testing. Preparation of equipment and instrumentation for further use in analytical assay and/or microbiological testing. Perform environmental monitoring activities such as collecting viable air, surface EM samples, non-viable particulate samples, and reading of EM plates. Support to maintain cleanroom environment below alert limits by participating in and following established cleaning practices and cleanroom behavior

The Packaging Engineer II procures and develops packaging for new and existing products. A Packaging Engineer II leads packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other Engineering personnel.

The primary purpose of the Quality Engineer (Post Market) position at Cook Winston-Salem is complete and review post market quality engineering activities, including complaint investigations, risk assessment, post market feedback, and product quality issues. Responsibilities include: Perform complaint investigations, including technical assessment of returned products. Complete risk assessments using post market data. Assist with the investigation, risk assessment and resolution of product quality and quality system issues. Implement, support and maintain post-production quality activities.

Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position. This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

The Clinical Research Associate completes project activities associated with monitoring functions of phase I through phase IV clinical research studies while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and applicable local regulations; provides clinical and technical support for CRAs and administrative staff; and performs management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.  Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations.  Responsible for research, development and production manufacturing activities associated with oligos. Responsibilities include: Independently produces notebook, dev, pilot and production materials per written directions, Analyzes in-process and final oligos using state of the art analytical techniques, Troubleshoots simple manufacturing process problems, etc.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.

We are currently seeking an Operations Test Associate responsible for generating accurate and reliable data for biologic products or medical devices on stability. Responsibilities include: Performs data analysis and results interpretations comparing to stability protocol defined specifications, validity criteria, and alert limits. Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials. Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed. etc.

Cyprotex US, an Evotec Group, is looking for an Associate Scientist (Cell Biologist) based in Watertown, MA to assume responsibility for the routine screening of compounds in various in vitro ADME assays and reporting to the Associate Director or Senior Scientist. Responsibilities include: Design molecular or cellular laboratory experiments, oversee their execution, and interpret results. Conduct research on cell function, including mechanisms of gene expression, cell signaling, or cell differentiation. Compile and analyze molecular or cellular experimental data and adjust experimental designs as necessary.

The Research Associate will work closely with colleagues in platform development, biology, and pharmacology. In addition, the Research Associate will be responsible for restocking lab supplies and maintaining lab equipment. Core responsibilities include: Conduct whole body perfusion and collect tissue for histological analysis. Micro dissect and process inner ear tissues. Perform immunohistochemistry staining protocols. etc.

This position will report to the Senior Scientist – Enzymology in the Lawrence, KS research facility. Key responsibilities include: Perform routine drug screening assays for kinase inhibitors. Quality control of high throughput screening equipment. Together with supervisor, responsible for validating new biochemical assays and troubleshooting when needed to establish reliable screening platforms. Track and record data into corporate database and notebooks. Generate reports and create presentations as required by the organization.

Dendreon’s Immunotherapy Sales Specialist is responsible for achieving sales objectives in an assigned territory through the development, maintenance, and enhancement of the business. Customers include oncologists, urologists, nurses, pharmacists, pharmacy and therapeutics groups, tumor boards, teaching institutions, hospitals and formulary committees. The role is responsible for ensuring customer’s clinical conviction in the product as well as guiding the customer through the logistics process and seeing the sale through to its conclusion.  The territory alignment for this role is the state of Virginia. 

Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.

Under the direction of the Operations Mechanical Engineering Manager, the Mechanical Engineer provides technical support for the projects, functions, and strategic objectives of the Operations Mechanical Engineering department, focusing on: engineering support for new product development; development of fixtures and equipment as standalone and in support of automated systems; failure mode analysis and corrective action of process equipment and instruments; sustaining engineering for the legacy and newly deployed manufacturing systems; engineering and quality documentation development.

Responsibilities to include: Performing key assays to support drug discovery using biochemistry, cell biology and/or biophysics. Generating high-quality, reproducible data by leveraging liquid handling, laboratory robotics and advanced data analysis tools. Identifying and developing new assays as the project requires. Communicating experimental results to project teams.

Dicerna Pharmaceuticals is looking for a BS/MS scientist to help in its drug discovery efforts. This is a hands-on research position that requires strong expertise in molecular and cellular methodologies. Key responsibilities include: siRNA drug candidate screening, hit identification, and lead optimization. In vivo drug candidate testing (e.g. mouse dosing; sample analysis)

The technologist assistant assists the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. The technologist assistant demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual demonstrates knowledge of the principles of growth and development over the life span. He/she is able to identify and categorize each patient’s age-specific grouping of needs, such as those for infant, pediatric, adolescent, adult or geriatric patients.

Under the direct supervision of the site physician, performs various professional and administrative duties related to nuclear medicine stress testing including but not limited to: patient preparation-including IV start and EKG lead placement interpretation, administration of exercise and pharmacological stress tests, and application of ACLS measures to patients when directed. Activities not performed at the physician site are supervised by the Area Supervisors and Business Directors.

Utilizes a developing to full understanding of operational processes and procedures to perform an assortment of assembly activities of moderate scope on a mixture of products, components, assemblies or sub assemblies. Follows methods, and sequence of operations according to specifications, blue prints and bills of materials. Ensures quality and product conformance. Sets up assembly for production. Performs various tasks which may include but is not limited to: wiring, component installation, hand soldering, cable harnessing, welding, painting, milling, filling, sewing, templating and fitting on assembly units. Performs maintenance responsibilities as needed and keeps surrounding area clean, safe and organized. Develops and recommends new methods to improve processes. Follows and complies with Company policies, standards and practices.

Job duties include: Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing. Identify software defects and submit problem reports via bug-tracking system. Perform regression testing on fixed issues.

Editas is seeking a highly motivated Research Associate I/II to join our Screening Team. In this role, you will contribute to the pre-clinal development of gene-edited cell products. An ideal candidate should have a strong background in cell and molecular biology. Demonstrated culture experience with both IPSC or primary cell lines and a strong interest in genome editing. Experience and interest with lab automation and liquid handling robots, Biomek Fx / I7 or similar, is a plus.

Looking for a contract worker to confirm contacts we have on file. Job mostly involves searching on LinkedIn and company websites. Must be able to accept payment via PayPal. Must be eligible to work for any U.S. Employer. Send a message through our contact form.

The incumbent will be a member of the QA-Engineering team at the Holly Springs Influenza Vaccine manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations. The QA-Engineering Specialist applies Seqirus quality principles related to equipment qualification, method validation, process validation, Cleaning validation, shipping validation and technology transfers. Utilizes integrated commissioning and qualification principles to ensure compliance of equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (or be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Responsibilities include: Ability to learn basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)

The Quality Engineer will be responsible for oversight and management of open items in the TrackWise system and help facilitate closure of items to achieve site quality goals. This role will help manage all open items to ensure items assigned to others are being completed in the required timeframe and/or assist with updating scope or completion timeframe. This role will also provide hands on work such as completing training, revising documents, completing investigations/CAPA, and executing action plans as it pertains to Project Records (PR) within the TrackWise system.

As an Analytical Scientist in our Quality Control unit, you will perform release and stability testing of materials for manufacturing of drug substances and drug products including raw materials, starting materials, intermediates, excipients and cleaning samples. You will operate HPLC, Dissolution, GC, KF, FTIR, and other laboratory equipment in a cGMP environment. Additionally, you may write standard operating procedures (SOPs), stability protocols and reports.

QA Specialist II will be required to: Support the quality team to achieve quality goals. Assist the quality team daily to accomplish efficient and effective review and approval of records as assigned including, but not limited to: calibration and maintenance work, procedures, validation protocols, validation reports, deviations and change controls. Communicate effectively with internal personnel, as well as external customers (if applicable).

This role has the responsibility to assist in developing and maintaining site research relationships, ensure sites are appropriately trained on JIT research technologies and clinical trial portfolios, and ultimately create an outstanding site research experience. The individual will work closely with the Senior Director, JIT Trials and JIT Network Manager to develop and execute network management and development programs. Arrange and organize sales oriented presentations or trainings for new research sites interested in joining the JIT Network and/or current sites in the JIT Network.

The Field Support Engineer I, under close supervision and direction, installs, repairs, upgrades and performs preventative maintenance on specified Carl Zeiss Meditec instrumentation in a designated field service territory. Represents Carl Zeiss Meditec at customer locations and works to achieve a high level of customer satisfaction. Maintains all company property (inventory, tools, diagnostic equipment, vehicle, etc.) in accordance with company policies. Maintains a high level of professional communication with team, customers, management, Sales and Technical Support.

The job involves training and working with scientists and microscopy users across the territory on a regular basis. The Field Applications Scientist will represent ZEISS as an expert in topics including, but not limited to Widefield, Confocal, Airyscan, Superresolution, Lightsheet and Automated microscopy, Image Processing and Image Analysis. Exceptional documentation and organizational skills are essential to succeed in this position. In addition to effectively communicating complex microscopy concepts to our customers, effective coordination between members of the sales and service team is an integral part of the daily routine.

The position will be responsible for downstream purification of recombinant viruses and will be a key member of the team developing expression and purification strategies for novel gene editing/gene therapy vectors. Responsibilities include: Contribute to a smart, integrated development approach for definition of scalable viral vector processes and suitable control strategies. Plan and perform experiments to develop purification process steps including chromatography (affinity, IEX, HIC, SEC, etc.) and filtration (depth filtration, UFDF, and sterile filtration). Perform experiments to develop robust downstream unit operations, using DoE, multivariate analysis, and other statistical tools.

The individual should possess strong core competencies in cell biology, molecular biology, assay development. Responsibilities include; Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Aid in conducting genome-wide CRISPR screens for novel target ID. Use mouse tissue to both aid in the development of novel biomarkers and analyze key targets by protein and gene expression.

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position. Work hours are Sunday to Wednesday (4/10). Responsibilities include: Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

Catalent has an opening for a Laboratory Associate Buffer Preparation, Manufacturing position. Responsibilities will include performing aseptic techniques within a clean room environment. As the Laboratory Associate Buffer Preparation, Manufacturing you will learn to execute and properly document biomanufacturing activities. Work schedule is Wednesday to Saturday, 7:00 a.m. to 5:00 p.m. CST. Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH).

The Formulation Tech reports to the Production Manager. The position is entry level and responsible for learning the basic BFS technology, personal protective equipment, equipment use, and comprehension of formulation processes and methods such as: tank sterilization process, temperature recorder function, reading set-up drawings, tank compounding, and batch record documentation. This position is responsible for aseptic gowning certification as prerequisite to entering the Aseptic Suites. New hire is not intended to stay in this position long term. Once training and qualification is completed at this level, employee advances to Formulation Technician Level 1.

Responsibilities as a clinical data programer include: Provide data programming support to project teams for reporting and analysis of clinical data in early clinical studies. Develop, maintain and process SAS programs for standard studies that create case report forms (CRFs), edit checks (clinical), data listings, analysis data sets and electronic data transfers.

Responsibilities include: Verify Excel spreadsheets and calculations. Assist in paperwork routing, document assembly, and verification of information packet completeness. Verify raw data against information in Methods or Standard Operating Procedures: Ensure Compliance with general SOP requirements, Verify Solution composition or concentration, including calculations used to determine the concentrations are correct, Verify volumes used and any processing step documented are as explained in the sample processing procedures

The Research Associate is a member of the Monoclonal Development team which is a core function for antibody development at CST. This individual will be responsible for preparing rabbit and mouse monoclonal antibodies as one of the key first steps in our product development process. This will be a focused role that will provide exposure to the broader monoclonal antibody development process. Coat and block plates for ELISA preparation, Process and document resulting ELISA data in accordance with CST hard copy and electronic laboratory documentation requirements (e.g. notebooks, electronic LIMS, Jira, PDP, PLM, etc.) Make culture media

We are seeking a Research Associate to join our Validation Systems Core (VSC) team within our Product Development organization. The VSC serves as a centralized resource for innovation in the culture, treatment, lysis, and storage of cell lines. The Research Associate is responsible for providing well-characterized, high quality cells and lysates to the organization to support Product Development efforts focused primarily on affinity research reagents such as primary antibodies, in addition to other product types such as assay kits, conjugates, and ELISA pairs.

Responsibilities as a manufacturing associate include: Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Maintain dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures. Set up and operate manufacturing equipment. Monitor machines and inform Supervisor and/or Lead of problems. Clean and maintain equipment and work area as needed.

Cepheid is looking for a Software Engineer to join our product software team developing molecular diagnostics applications using Java and Angular predominantly. You will be a member of the software team responsible for designing, developing, testing, and implementation of Cepheid next generation software products. Repsonbilities include: Design, develop, troubleshoot and debug software products using Java and Angular. Maintain robust software applications by participating in software debugging and testing. Adhere to software development and source control processes.

The Manufacturing Lab Technician I will work directly with Viral seed culture and Virus propagation techniques, prepare buffer/media solutions and equipment preparations, and inactivation methods following aseptic technique and cGMP procedures. Operators will be in a full gowned environment and will be need to use strict aseptic techniques.

Support in vivo oncology studies in mice as a member of Necropsy Services. Allocate animals to study. Assist with gross necropsies (dissection, tissue trimming/collection/preservation, sample collection). Perform preparation activities, including container and tube labeling and room set-up. Collect, process and maintain blood and tissue samples. Assist with the tracking and shipment of samples to sponsors and diagnostic laboratories.

Provide chemistry and formulation support for vivo oncology studies. Collect and document pertinent data, including lot information, COA, and MSDS, for the receipt, distribution, preparation and disposition of test compounds, reagents, and carriers/vehicles in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines. Prepare and dispose of test materials, vehicles, and reagents according to study protocols and SOPs. Monitor test materials and help maintain facilities for cleanliness, safety, and regulatory compliance. This includes glassware and waste processing.

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Perform within the Bacteriology laboratory process internal and external rodent samples by for microbiological identification. Reconcile customer paperwork with submission documentation to ensure accuracy. Make detailed observations and maintain documentation of all laboratory work. Comply with all Standard Operating rocedures (SOPs) and operating equipment and hazardous and non-hazardous chemicals and biological material according to laboratory safety policy

The following are responsibilities related to the Quality Assurance Auditor 1: A Quality Assurance (QA) Auditor I is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

The Technician I will perform routine animal husbandry and other production duties, and maintain supplies and environment of environmentally-controlled work area(s). Other essential duties and responsibilities include: Perform routine animal husbandry duties and monitor daily health and welfare to maintain quality and health of animals. Handle, transfer, and distribute animals, supplies and waste as needed to and from work area(s). Perform physical environment housekeeping duties and production operations according to Good Manufacturing Practices (cGMPs) and/or Standard Operating Procedures (SOPs). Maintain recordkeeping pertaining to equipment operation, animal or supply area inventories.

This position will be responsible for handling and processing samples, and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies.

Primarily to assist in the regulatory filings of new products as 510(k), PMA and / or BLA submissions for in-vitro diagnostic devices as well as post approval related regulatory filings for the lawful marketing of Chembio products. Review change control process as it pertains to reportable changes to FDA CBER and CDRH. Assist in 180-day supplements and clinical filings to regulatory agencies etc.

Perform multi-step organic synthesis in solution and/or solid support: Optimize conditions to achieve desired yield; perform and interpret data analysis such as LC/MS and NMR; perform purification steps such as extraction, recrystallization, silica gel column chromatography and LC/MS purification; perform cGMP synthesis of pharmaceutical ingredients; and perform process development and scale-up for kilogram quantities; and clearly record and communicate results and challenges to coworkers/supervisor. Equipments and tolls used included NMR, UV, MS and IR, Reactor (from 50ml to 221 to 10000l), vacuum pump, water aspirator, condenser, rotavap, voltage transformer, chromatography columns, TLC monitor, lyophilizer, separation funnel and addition funnel.

Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise. Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials. Assist in the evaluation and management of CROs and other vendors and systems. Negotiate and manage contracts/budgets with CROs and other vendors.

In order to support cochlear implant clinics and recipients, we are recruiting for an Insurance Verification Specialist. To be successful in this role, you will facilitate all pre-claim activity for reimbursement orders while providing exceptional service to internal and external customers. You will act with a sense of urgency to address inquiries while demonstrating a high degree of knowledge, integrity, and empathy in all aspects of team performance and operations.

The Clinical Research Coordinator I (CRC I) is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the philosophy and mission of the company. The CRC I plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned research projects. The CRC I follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff, sponsoring agencies, and others to effectively perform clinical research and to coordinate research activities. All duties carried out by the CRC I are done so in accordance with company policies and SOPs, as well as all applicable local, state, and federal regulations. Professionals in this role actively participate in outstanding customer service and accept responsibility for developing and maintaining mutually respectful relationships.

Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by: Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams. Creating and executing manual test scrips which includes testing software applications for quality and functionality using defined validation protocol and testing techniques. Working with application developers in resolving issues and retesting applications. Partnering with technical and business teams to achieve understanding of current and future functionality.

The Laboratory Assistant must demonstrate knowledge of specimen collection and processing and handling requirements as relevant to Bioclinica Research and must have a thorough knowledge of lab procedures and practices. Responsibilities include: Perform blood draws, specimen collection, take vital signs, perform EKG testing and able to record accordingly. Timely specimen preparation for processing and shipping. Effectively and professionally interact with patients, visitors, peers and other healthcare professionals

Biodesix is accepting resumes for a Laboratory Technician to process molecular and proteomic Laboratory Developed Tests (LDT’s) from blood based specimens. Laboratory Technicians must have the technical training and experience required to perform regulated clinical laboratory testing, including sample accessioning and processing using standard in-vitro laboratory techniques which include DNA and RNA extraction from whole blood, ddPCR (digital droplet PCR), Mass Spectrometry for proteomic testing and to operate a proprietary LIMS.

The primary functions of this position include culturing, setting up, feeding, maintaining, and harvesting of bioreactors with hybridoma cells, finding, testing, and developing new procedures to increase the quality and efficiency of our product and processes, and maintenance of regularly used equipment. This position offers a varied work load and will enable you to gain solid experience that will allow you to grow and increase your skill set within a fast-growing and stable biotech company. This position will also allow you to gain experience in all areas of tissue culture and cross training on a variety of other supporting tasks such as downstream processing, ELISA assays, qPCR, mycoplasma detection, and NOVA BioProfile 400 use and maintenance.

The Manufacturing Associate will be an integral member of a team that ensures the highest quality of our finalized antibody products. This position offers the opportunity to gain experience with different types of conjugation chemistries and different chromatography methods to purify antibodies and offers the opportunity to work in small scale to large scale product projects and to learn to utilize the (Enterprise Resource Planning) ERP database to track production schedules and deadlines and to enter production results. This position will also perform scale ups and perform troubleshooting of problematic products, including continuous improvement methodologies for efficiency.

BioLegend has an immediate opening for an ELISA Research Associate who will become an active member of our team who develop high quality ELISA products including proteins, antibodies and assay kits. The Research Associate will participate in all stages of the produce development process from product design, material sourcing, optimization, validation and product launch.

This position is responsible for developing recombinant protein research products in the Molecular Cellular Immunology group by using cutting-edge synthetic biological technology. The duties include preparing buffer solutions and cell culture media, performing bacterial, insect, and mammalian cell expression, purifying recombinant proteins with chromatography, and performing molecular cloning, PCR, and DNA purification according to standard operating procedures. This position offers a significant opportunity for learning protein production techniques and career growth in biotechnology industry.

We are looking for highly motivated and hardworking Research Associate I/II for molecular biology and AAV production to coordinate and perform activities required to generate early stage material for the therapeutic programs at discovery stage. Responsibilities include: Operations of bench-scale bioreactor, Cell culture for insect and mammalian cell lines, Molecular cloning and PCR based quantitation

The Research Associate will be part of a stablished team of scientists and RAs working to develop and optimize AAV vectors production processes and assists team members in molecular biology and cell culturetasks including:Nucleic acid/plasmid purification. Cell propagation and plasmid transfection.Clone screening and selection. DNA analysis by agarose electrophoresis. PCR. DNA quantification by qPCR or ddPCR. etc

This technician works within a project team under the leadership of a more experienced individual such as a team lead, project lead, or project manager. The technician is expected to perform various types of technical activities including design, development, testing, verification, and documentation. This technician is expected to work and communicate well with other members and leadership of the team in order to meet the goals of the project.

This position requires an individual with strong problem solving skills, good laboratory technique, and the ability to execute complex experiments. The successful candidate will have a desire to learn and the strong attention to detail. This position will entail running of automated oligonucleotide synthesizers as well as synthetic chemistry and/or molecular biology laboratory work to support new product development.

Responsible for design/development, modification, and evaluation of primarily mechanical systems, equipment and packages. May contribute to total systems engineering, including other eng. disciplines. Conducts feasibility studies and tests new and modified designs. Is involved in all phases of development from initial concept to manufacturing. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation. Depending on level may function as a project engineer/leader with the resident responsibilities of proposals/project plan, schedules, work assignments, prime contact, technical presentations, cross functional issue resolution, etc.

The responsibilities of this position are production, bottling, and packaging of methylcellulose-containing and other cell culture media. Perform QC testing of methylcellulose-containing cell culture media. Perform cell culture of multiple cell lines. Production of components for additional stem cell, and non-stem cell kits. Skills used include cell culture, high attention to detail, strong communication and organizational skills. Perform additional duties as assigned. This will be a Sun through Thurs work schedule.

The responsibilities of this position are to characterize monoclonal and polyclonal antibodies on natural samples using Western blot and Simple Western. Screen multiple sera or hybridoma culture supernates to select potential products. Validate purified antibodies using natural samples. The person will develop problem solving and decision-making skills, while maintaining appropriate contact and communication with the supervisor. Maintain and treat cell lines for needed lysates. Refer to pertinent literature, databases and competitor product information on specific antibody targets. Maintain clear notebook, enter data in PDPT and perform calculations.

The Manufacturing Chemist I is responsible for processing and formulation of controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for manufacturing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to manufacturing in a laboratory environment.

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as a microbiologist and molecular biologistas part of a team developing new strains for the production of antibiotics, enzymes, metabolites, and proteins. The position involves generating and improving strains using strain engineering molecular biology techniques or classical mutagenesis,screening and selection.Routine microbiology tasks

This position will provide support for clinical research functions of project teams by supporting all aspects of project initiation through project closure. This will include performing administrative functions, maintaining general and study site files, data entry and interfacing with site coordinators, field clinical staff and other company representatives, as well as other project-specific duties.

(Associate Level) Executes routine unit operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Non-Lab position. The Sample Management Technician is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. This position reports to the manager of Stability and Sample Management. The Technician’s responsibilities include, but are not limited to, the following: Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs, inventorying and disposing. Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork.

The Process Engineer I is responsible for developing and maintaining capable processes and ensuring efficient and effective sterilization operation. This person will apply problem solving skills to enable sterilization innovation while using technical and collaboration skills alongside his/her passion for innovation and continuous improvement to drive growth through efficient and effective process improvements. Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.

The Scientist will provide biologics process development support to ensure that the Brammer Bio Downstream Process Development (DSPD) unit operates to provide clients with new purification methods and investigational materials for pre-clinical and clinical use. The incumbent will assist in the design and execution of experiments under the supervision of the technical project lead. This will involve researching and sourcing reagents, equipment, and materials; preparing columns; purifying viral vectors utilizing working knowledge in filtration technologies, column chromatography (SEC, affinity, HIC, AEX), ultracentrifugation and scale up principles. This position will also be expected to technically review data, prepare experiments/data for presentation, participate in laboratory investigations, interpret this data and work with the project lead to trouble-shoot technical problems. The incumbent will participate in the optimization of purification methods and the writing and troubleshooting of protocols. The incumbent is expected to prepare and modify documents (SOPs, Batch Records, Raw Material Specifications, etc), maintain a GLP culture, and assist in maintaining the process development laboratory.

The primary responsibility is to support the technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Manufacturing, Process Development, and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products. Supports cross functional technology transfer teams for cGMP DS manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Includes authoring of upstream or downstream plan documentation and associated detail process descriptions (DPDs).

Responsibilities include: Conduct experiments to support cryogenics manufacturing processes of commercial and late-stage biologics drug substance. The candidate will support bulk container selection and freezing, storage, and thawing operations for biologics drug substance. Support validation of the freezing and thawing processes of commercial and late-stage biologics drug substance across BMS global network and contract storage/manufacturing sites. Follow appropriate GLP/GMP procedures. Study design, execution and analysis of results, data verification, preparation of study protocols and final reports, and the presentation of findings at internal and external forums

This associated scientist position within the analytical methods team has the opportunity to drive the development and validation of robust separation methods (e.g., CE-SDS, iCIEF, SEC, RP, IEX, HIC) for biotherapeutic drug candidates in the portfolio spanning early and late stage clinical programs. Bristol-Myers Squibb's biologics pipeline includes approved biologics products such as OPDIVO®, YERVOY®, EMPLICITI®, ORENCIA®, and NULOJIX®, and a number of exciting clinical stage compounds as well as antibody combination products. Development of methods utilizes state-of-the-art analytics as well as modern concepts of quality attribute monitoring of biotechnology products. Science-based research and molecular-level understanding of protein properties are critical for successfully performing method development. Innovation is central to establishing robust analytical control and define our overall biologics development strategy. The successful candidate will also support regulatory filing activities including IND and BLA, as necessary. This position reports to manager in Methods and Analytical Development function of the Biologics Development organization.

Support the operation of GMP / Non GMP manufacturing systems (Systems include Process Automation Systems, Manufacturing Execution Systems, Process Development, Technology Transfer, Laboratory, Manufacturing Operations) in the associated facilities. Provide Troubleshooting support and guidance of systems in support of manufacturing, process development, and/or Lab operations within a collaborative team. Collaborate in investigations of proprietary automation software/hardware, manufacturing operations, process development, along with vendors when necessary. Documentation of data and results, data verification, interpretation of small scale and at scale data supporting the manufacturing processes and preparation of final reports to summarize the findings.

As a Manufacturing Quality Engineer, you will be the primary quality interface for new and existing products. You will design, develop, and execute quality assurance and control systems. Use your expertise and judgment in implementing a wide variety of quality concepts, practices, and procedures. You will contribute to product and manufacturing process design, as well as the methods for verification and validation of product to ensure adherence to company and customer requirements. You will work toward the prevention and/or resolution of product and manufacturing process non-conformance. You are well versed in working with Contract Manufacturers (CM) and Component Suppliers. You will lead teams to ensure products are designed and built to Bruker’s high standards of quality and performance. You will evaluate the product designs and create the processes, tools and procedures behind Bruker’s world leading Handheld X-Ray Fluorescence (XRF) products. You will collaborate with Commodity Managers and Design Engineers to determine Bruker’s manufacturing and product specifications

Responsible for coordinating and providing engineering support throughout the manufacturing facility in areas such as process improvements, technological advancements, cost improvements, facility maintenance, safety, and environmental regulation. Coordinate and participate in plant CIP and process improvement programs as required.Support, or lead as required, activities such as failure investigation, design of experiments, process capability studies, qualifications, and validations of processes and equipment. Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications, or enhancements.

As a Quality Engineer I, you will learn and develop skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team. Responsibilities include: Conduct experiments to prove hypotheses. Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques. Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports. Perform root cause investigations for design and manufacturing

This list is not comprehensive but meant to represent the most common or important duties of the position. Develop, document and implement standard molding processes and methodologies. Use scientific molding method to validate new molding processes and re-validate existing/legacy molds. Research, design and develop manufacturing processes and new technologies. Participate in Tool Design Reviews and recommend improvements to optimize molding, setup, and overall manufacturing. Work with design, manufacturing, production, engineers and tooling during the entire development cycle. Emphasis on new mold sampling prior to transfer to production. Research, develop and implement manufacturing process controls, machinery modifications and improvements.

This is a hands-on lab-based role in Induced Pluripotent Stem Cells (iPSCs) group with a focus on iPSC genome engineering and differentiation using ASC’s gene editing technologies. Responsibilities include: Work closely with a multi-function team to deliver engineered iPSCs cell lines and a variety of other cell types. Work on gene editing projects in iPSCs/stem cells, preparing reagents, performing cell culture and cell-based assays. Work on iPSCs generation, differentiation and characterization. Apply scientific knowledge, critical thinking, and problem-solving abilities to troubleshoot and refine methods and assays. Interpret genotyping data from Sanger sequencing and Nextgen sequencing

The primary mission of our Technicians is to operate injection molding equipment to successfully meet production demands and quality standards. Duties include but are not limited to: Utilize your mechanical skills to install, remove and adjust Injection Molding machinery and equipment. Troubleshoot Injection Molding machines, follow process to resolve failures, other problems. Coordinates and sets up machines, robots and other equipment performing necessary tests to ensure company compliance. Trains employees in the correct procedures for operation as needed. Assist in preventative maintenance and repair of molding machines, molds and peripherals (robots).

At Arbor, Research Associate Bioengineers use a combination of molecular biology, high-throughput techniques, and next-generation sequencing to systematically search through nature’s gene diversity to discover and engineer new protein technologies. In this interdisciplinary position, you will be expected to perform high-throughput functional screening to further Arbor’s mission of biodiscovery, and accelerate the company’s platform technologies through protocol development and testing.

The ideal candidate will have significant research or industrial experience in protein purification, assay development and optimization. They will also possess a strong background in molecular biology, excellent organizational skills and attention to detail, as well as a strong desire to learn and the ability to work independently. Responsibilities include: Routinely perform the established assays. Optimization of assays to increase throughput and performance . Document, compile, and analyze experimental data. etc

The job requires the application of creative problem-solving approaches to the execution of new biochemical and cell-based assays. Responsibilities include, but are not limited to: Performing routine assays to support chemistry efforts. Execution of new biochemical and cell-based assays. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results. Utilizing liquid handling systems and laboratory robotics to implement in vitro assays. Contribute during lab meetings and assist in the analysis and reporting of experimental data to project teams.

The Biology group is seeking a self-motivated, collaborative and highly skilled individual who wishes to play a key role in advancing novel immunotherapy drug candidates from the discovery phase into the clinic. The data generated by the in-vivo team is central to advancing our understanding of the mechanism of action of our drug candidates and potential combination partners. Specific responsibilities will include collaborating with the project team to conduct tumor efficacy studies in both syngeneic and xenograft models. In addition to taking point on in-vivo efficacy studies the successful candidate will be involved in the ex-vivo analysis of tumor samples. Additional duties could also include in-vitro responsibilities such as the maintenance and preparation of cell lines for tumor studies.

This role will be responsible for QA oversight of all GxP Computer Systems. The incumbent, working with the functional teams must ensure that all GxP regulated systems are purchased, audited, installed and maintained based on industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position plans and organizes all QA activities for computer system validation projects. Duties include, but are not limited to, oversight and approval of validation - related documents, leading risk assessments and working with project team to determine which elements should be validated, conducting and/or coordinating impact assessments of proposed changes to computerized systems and leading inspection (external/internal) readiness activities related to computer system validation. The candidate will ensure that all GxP computer systems are maintained in a validated state in addition to designing work processes for users and administrators of the aforementioned systems.

We are seeking a highly motivated Cell Culture Biologist with excellent organizational, problem solving, and communication skills to join our Structural Biology group located in Boulder, Colorado. This scientist will be responsible for maintaining and scaling up (≥5L) insect cell and E. coli cultures in suspension for recombinant protein expressions. The individual will also be involved in molecular cloning and construct design. A track record of excellent aseptic techniques and experience in molecular biology and protein expression are essential for this role.

This is an ideal position for an individual with an organic or biological chemistry background who has an interest in projects related to novel technology in synthesis and purification of oligonucleotides and bioconjugates. The successful candidate will be expected to: Perform solid-phase synthesis and purification of oligonucleotide drug candidates. Analyze small-molecule and macromolecular targets using standard methods, such as HPLC, UV-Vis spectrophotometry, mass spectrometry, NMR, etc. Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings

We are actively seeking an Automation Engineer I to provide automation and equipment development and support expertise to the Final Device Assembly and Packaging engineering group. This engineer will be a resource for all activities required to build, program, install, debug, and implement automated equipment. The successful candidate will have strong communication and analytical skills, knowledge of manufacturing process and a Bachelor’s degree in Engineering or Engineering Technology.

Under the direction of the Program Manager and Clinical Trial Manager, the Clinical Research Associate I contributes to the tactical implementation and conduct of clinical research studies. The CRA I ensures the quality of each research study through on-site and centralized monitoring of protocol and regulatory compliance. The CRA I represents Myriad at the research site level and maintains collaborative relationships with investigator sites and the internal clinical development team. This position can be based in Salt Lake city, Utah or Mason, Ohio.

The Process Development Research Associate 2 will work as part of a team evaluating processes, and planning/executing experiments to improve all aspects of culturing, gene-editing, and engineering of pluripotent stem cells. The Research Associate 2 will acquire further versatility in routine procedures, technical knowledge, understanding of administrative operations, and general troubleshooting. Will assist with complex laboratory operations and take on more responsibility to provide content for various documents and reports. Will be able to execute protocols with minimal guidance and will have the ability to summarize results independently.

In this position, the successful candidate will apply their skills and expertise in protein biochemistry to identify targets bound by patient derived antibodies using protein biochemistry and molecular biology techniques. These include protein and carbohydrate arrays, immunoprecipitation, and other protein biochemistry techniques. Responsibilities include: Perform immunoprecipitation and array screening of antibodies selected for testing in in-vivo tumor models. Generate lysates and subcellular fractions from tissue culture cells (including radiolabeled cells) and mouse tumors. Perform pilot immunoprecipitation screens on lysates from tumors and radiolabeled cells.

The Associate Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative ways to achieve the company’s goals of producing market leading products through positive patient outcomes. Responsibilities include: Team member of projects involving design, manufacturing, and quality resources, both internal and external. Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume manufacturing processes. Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts

This entry-level position is within our production group. The work includes following standard operating procedures for using automated liquid handling stations, interfacing with our in-house database, providing support in various lab functions including PCR, making agarose gels, growing culture from stock, organizing/purging storage plates, and interacting with our bioinformatics department.

We are currently hiring a field-based Specialty Pharmaceutical Sales Representative who will be able to drive branded prescription sales in their assigned territory. The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN’s offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share.

This is an entry level position in a chemistry-based contract research organization. A background in the sciences, particularly chemistry, is preferred. Responsibilities include; Reporting to the Manager of Quality, responsible for logging in samples and chemicals for use in the laboratory. Keep chemical inventory program up to date. Keep chemical storage areas free of expired chemicals and uncluttered. Ensure chemicals in the laboratory are in the correct locations. Ensure glassware is in properly labeled locations

Must be bilingual (English and Spanish). Responsibilites include: Provide technical support to Manufacturing, Engineering and Quality areas. Improve manufacturing processes. Participate on the evaluation of customer complaints and provide suggestions for process/product improvements. Generate validation protocols and reports for the qualification of process equipments or process changes. Develop and update standard operating procedures for new and existing processes and equipment.

Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner. Essential Duties and Responsibilities include: Operate lab equipment such as laminar flow hoods, autoclave, incubators, and other equipment. Read plates and enter test results and other data into LIMS. Initiate paperwork for microbial out of limit investigations and provide needed information to Investigators. Perform monthly safety audits

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Responsibilities include: Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaints. Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.

Responsibilities as Engineer II include: With supervision, perform standard engineering assignments which are typically a significant portion of a larger project. Lead small project teams through the planning, execution, and completion of smaller projects or defined pieces of larger projects. With supervision, lead projects within Baxter’s change control management process, from initiation through closure. Change Owners assign and prepare impact assessments, develop change plans, write and execute engineering studies, while working closely with manufacturing plants, quality, regulatory, purchasing, and various scientific/technical groups.

The position will allow someone who has completed advanced studies in a science or engineering field or a physician to work closely with the radiologists, engineers and physicists at Bayer and take on a project that supports the use of contrast enhanced imaging and associated informatics software. They will be able to understand what the scientists and physicians do in Radiology at Bayer through an in-depth project. A specific project that fits their background and training will be assigned. Projects typically involve the investigation of improvements to imaging in radiology. They involve programming, data analysis and innovative thinking. They may also help develop scientific materials for presentations and help answer scientific questions internally and externally with collaborators or customers.

The Sample Management Technician is responsible for GxP-compliant processing of incoming and outgoing samples and reference materials. Responsible for GxP-compliant accessioning of incoming samples and reference material, as well as the outgoing shipment of samples, reagents and reference materials. Reviews study sample demographic data to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS). Resolves discrepancies, with responsibility for investigating and correcting sample anomalies identified in the eSMS system.

We are currently looking for an enthusiastic research associate to join our manufacturing team. This position will entail preparing reagents for our assay kits, QCing and packaging the finished products. This candidate may also join part time in our R&D team.

Medical Assistant works in a clinic setting and handles basic clinical task and performs administrative/office duties. Interacts with patients and assist physician to ensure operations run smoothly and efficiently. Answer incoming calls, take messages and/or respond to all calls within 24 hours. Schedule patient appointments. Perform clinical task including but not limited to vital signs and height/weight; document medical history in patient charts. Prepare patient for examination. Ensure examination room is clean, well-equipped, and ready at all times

You will beresponsible for developing applications and products for Opal Multiplex Fluorescent IHC Reagents which are designed specifically for Akoya’s cutting-edge Mantra and Vectra Polaris multispectral imaging systems.The desired skillset for laboratory work includes the ability to perform immunohistochemistry (IHC) procedures to support theproductdevelopment. Your work will involve manual laboratory work and the use of automated stainersystems for monoplex and multiplex fluorescence tissue staining.

To conduct formulation preparation or analytical test in direct support of the drug development team, including writing documents and reports. Responsible for the maintenance of lab instrumentation and general lab duties. Prepare drug formulations according to established procedures. Analyze test data, recognize results that are abnormal or deviate from those expected. Recognize equipment malfunction and factors affecting measurements and testing. Evaluate and solve problems related to sample preparation, variation and processing

The Associate Scientist II, under the direction of a senior scientist, executes chemical reactions on a gram to multi-kilogram scale and performs routine analytical procedures to monitor reaction progress. This role requires the incumbent to efficiently organize routine work with supervision and properly evaluate and interpret generated data. Exercises judgment within defined procedures and practices to determine appropriate action. The Associate Scientist II will exercise judgment within defined procedures and practices to determine appropriate action

The Analytical Chemist I is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of active pharmaceutical ingredients development or pharmaceutical manufacturing. This position may also be required to work on method development/method validation projects. Typical types of testing include: assays (potencies, related substances, residual solvents, metals etc.), moisture content, identification, and various other wet chemistry based measurements. HPLC and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: titrations, UV, DSC, TGA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by Alcami).

Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff. Responsibilities include: Carry out production tasks in support of manufacturing goals and objectives. Operate laboratory equipment safely, as trained and directed, in accordance with established practices. Maintain records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system. Report results to supervisor. Perform complex formulations, component and material evaluations, equipment calibrations and maintenance

The position of Production Specialist I is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Duties include: Performs work required for the assembly of components, devices and/or the final product with supervision. Ensures quality of product using standard operating procedures, templates, training and supervision, and good judgment.

Responsibilities include: Conduct research on various drug/device interactions as part of the drug delivery and device development process. Analyze and interpret data from various product development experiments. Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project objectives. Contribute to stability studies. Ensure reproducible and reliable results for protocols related to development of drug delivery systems.

The role will use in vivostudies to primarily assess CNS mechanisms through rodent behavioral, histological and biochemical techniques. The role is critical in assisting the scientific team in advancing our therapeutic understandings. This person will be involved in establishing, validating, and implementing methodologies in Alkahest’s laboratories and is thus pivotal to the company’s mission. The studies performed will involve cutting edge science and require innovative concepts and strategies. The role requires dedication to drive science, flexibility, excellent communication and organization, and will interact with a team of scientists and research associates to drive multiple projects in parallel.

Under the supervision of Regulatory Compliance management, the Regulatory Compliance Auditor/Analyst will support all aspects of the Regulatory Compliance processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified. Supports LifeCell’s internal audit program and performs assigned internal audits under the guidance of lead auditor in accordance with internal procedures and relevant standards/regulations.

The Lab Ops Associate is based in Irvine, CA and will support Allergan R&D by ensuring optimal operation efficiency of the laboratories. Primary area supported is Research and External Scientific Innovation, and includes multi-disciplinary interaction with EH&S, Managed Lab Services, Facilities & Corporate Engineering, and Pharmaceutical Development with emphasis on planning, coordinating and executing logistical lab operations. Responsibilities include: Scheduling technician visits and escorting the technicians into restricted lab spaces. Tracking research lab equipment including inactive, new, movement, and repair or calibration schedules.

The successful candidate will help to synthesize and purify oligonucleotides for research studies. Additionally, they will evaluate new chemical modifications for their use in the RNAi pathway via synthesis, purification, and characterization of synthetic oligonucleotides. Other responsibilities include: Utilize analytical instrumentation such as UV-Vis spectroscopy, HPLC, and/or LC-MS for the analysis of both crude and purified synthetic products. Effectively troubleshoot synthetic/process issues and independently find solutions. Improve upon and/or develop new methods and automation for the downstream processing of synthetic oligonucleotides and their subsequent analysis/purification and annealing into siRNA duplexes.

The Research Associate I is responsible for assisting senior ATG Lab staff to design and perform research diagnostic assays spanning a wide range of PCR and Next-Generation sequencing technologies. Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, and sequencing analysis. Aid in the design and development of diagnostic assays for use in a CLIA/CAP regulated setting. Participate in drafting Standard Operating Procedures for new assays.

You will be working in a team that is handling one or two applications. You will be getting requirements from a QA manager and will be with the QA development team. You are responsible for the documentation, development and execution of basic manual test cases. You will also be working with the application development team for creating data sets for testing, debugging issues, and improving products. Your end users are mostly internal and need to be able to support them when necessary.

Responsibilities include: Draw and design parts, fixtures, tooling and test equipment. Write programs for CNC machines and support the tool room in the manufacture of designs. Update all modifications to part prints and 3D data. Measure and determine proper machine function for finial sizing of components. Create new designs for products, production machinery, injection molds, and mold shop tooling and fixturing. etc

The successful candidate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable clinical advancement of Amgen programs. The successful candidate will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development.

Under general supervision, Associate Manufacturing will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Associate may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, Associate may identify, recommend, and implement improvements related to routine functions.

The Research Associate position will be responsible for supporting lab operations in the purification of target proteins and bio-reagents. Responsibilities include: Performing experiments for the bench scale purification of protein therapeutics and reagents. Performing necessary assays in support of both upstream and downstream activities. Supporting therapeutic protein drug substance process development and scale up. Evaluating technologies to improve downstream processes. Serving on departmental, interdepartmental, and project teams.

This position will be responsible for the transfection or transduction of gene therapy-related constructs for the characterization of protein expression efficiency and protein product characteristics across a wide range of therapeutic targets. Duties include: Maintenance of the appropriate cell systems for evaluation of protein expression. Transfection or transduction of transgene constructs into an appropriate cell system to evaluate protein expression and characteristics. Measurement of protein expression level and quality. Tracking progress of multiple protein expression projects and prioritization of parallel projects to ensure timely delivery.

The Safety Engineer works with the Supervisor to plan, direct and implement Amneal's environmental health and safety programs to ensure a positive, safe, healthy and incident-free work environment and is responsible for the compliance by Amneal with all environmental and safety regulatory agencies. Responsibilities include: Walk each plant periodically to observe operations and identify safety issues, assess and correct any problems. Ensure fire extinguishers are in working order, not blocked, conduct annual inspections with outside contractor, and verify that they are properly placed and hung. For NJ position: Weekly inspections of Laboratory and hazardous waste area required. Obtains OEL, SDS and SFS for all products with a focus on NPL and R&D projects. Ensures that proper information is communicated to user department and training is provided, as required.

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability.

Duties may include: Review and/or conduct investigations for process variances, product non-conformances OOS results. Ensure compliance of current processes and planned process improvements to cGMP. Be responsible for the timely review of records, to include confirming the completeness of the record and the accuracy of relevant entries. Manage the release of intermediates and final products in accordance with the approved systems, procedures and specifications..

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Performs test preparation and setup, and runs required tests for pharmaceutical raw material and finished products, such as bioburden, sterility and endotoxin tests. Performs a variety of tests which directly or indirectly affect product release, and test for the sterile quality of products manufactured by performing the following duties. Analyzes test data collected from experiments using laboratory equipment and chemicals to determine the sterile quality of products produced. Interpret EM plates and RCS strips. Identify isolates recovered from EM plates/strips and bioburden tests. Writes test results and submits reports including required calculations and statistical verifications.

Prepare, collect, and test plant purified water, manufacturing raw materials, product in-process, and finished product, and perform environmental monitoring. With limited supervision, learn and perform critical laboratory techniques and complete original work. Author problem reports and participate in investigations. This description is inclusive of EM and testing duties: actual percentages of time spent on each duty may vary based on business needs.

Under the supervision of the laboratory supervisor the Microbiology Lab Technician provides support tasks in a fast-paced laboratory setting. Funtions include: Media preparation, Glassware cleaning, Inventory / ordering, Lab cleaning and sanitization, Autoclaving various reagents and supplies, Assist laboratory personnel in daily activities to maintain high scientific quality and compliance with SOPs, protocols, and safety standards

This position is responsible for daily data entry as it relates to Contract Support related activities. This includes order processing, shipping paperwork, invoicing, advanced ship notices, product returns and other duties as assigned. Position Responsibilities: This includes: 1. Order Entry – Receipt/entry (EDI, Fax, e-mail). 2. Shipping/Invoicing – Prepare all docs pre and post shipment, maintain files, send invoices and advanced ship 3. CSII Orders – Process, verify, track orders, and maintain electronic 222 log. 4. Receive and update returns log for all return requests received by customers. 5. Evaluate each return to determine the appropriate return policy. 6. Create Disposition Authorization. 7. Coordinate with return company and/or customer on return or destruction authorization. 8. Create credit request for approval once material returned or destruction notice received. 9. Enter approved credits/debits into customer accounts. 10. Provide customer with credit and any supporting documentation. 11. Performs other duties as assigned or requested.

As a Process Engineer I, you will learn and develop skills related to sustaining and improving production manufacturing processes as part of a cross-functional team. Responsibilities include: Sustain manufacturing processes. Debug manufacturing processes and equipment via root cause analysis. Develop and update engineering documents such as process maps, process FMEA, manufacturing/quality Instructions, test methods, drawings, and test reports. Collaborate with the Engineering team for fixturing design and development, tolerancing and design for manufacturing

We are looking for someone to confirm/correct our drug pipeline data on a contract basis. You should have some knowledge of drug indications and clinical phases of drug development. If interested, send us a message via our contact form. Must be able to accept payment via PayPal

The RA in this role will conduct experiments to test and validate new automation processes for high throughput engineering of microbial genomes. They will help to invent new techniques, create cutting edge protocols, and extend existing Zymergen protocols to provide newer and better workflows to our microbe engineering Factory. They will work together with other scientists, RAs, automation engineers, and software engineers to deploy these new technologies into production. The RA will contribute to the overall mission of Zymergen by helping to bring new technologies into our workflows.

Zymergen is hiring Engineers into the Manufacturing Engineering group to focus on the continual improvement of manufacturing workflows across our factory. These Engineers are required to be able to identify and implement improvements in existing processes and establish protocols for new programs. Typical responsibilities will include: Operation of multiple types of robotic systems, including but not limited to, liquid handlers, colony pickers, barcoders, and automated plate readers for implementation of new or improved processes. Process modeling using a bpmn based MES and workflow optimization in collaboration with software and automation teams. Development and implementation of data tools (JSL, Python, R, etc.) to support existing workflows.

This role is for an RA that will be an integral part of carrying out the sequencing core’s most essential function - sequencing. In particular this role is for an Reserach Associate that will be skilled at PacBio library preparation and instrument usage. Responsibilities will include preparing PacBio Sequencing libraries, writing SOPs for library preparation and instrument usage, work with Bioinformaticians and Software Engineers and IT staff to integrate PacBio sequencer into existing or new infrastructure and prepare sequencing libraries for other instruments.

The candidate must be able to learn complex procedures, efficiently execute microfluidic characterization experiments, perform data analysis, and communicate results and observations effectively. Key responsibilities include: Perform experiments and analyze data to help us develop robust microfluidic consumables. Use your understanding of microscale transport phenomena and troubleshooting skills to engineer new products. Communicate results clearly and contribute data for making critical design decisions

Responsibilities include: Build applications, libraries, and services to make machine learning more available within the company. Expand the variety and complexity of machine learning modes we can use. Develop checks and tests to ensure we're delivering reliable, quality results. Optimize machine learning, computational, and data processing pipelines.

he person hired for the position of Cloud Analyst will work with the global process teams to build and deploy standardized global cloud solutions as part of the Polaris project. Responsibilities include: Design, develop and test data pipelines established to deliver data into data storage based on a function design specification. Analyze, design, code/develop and implement changes to resolve break/fix issues to resolve and close tickets during both testing cycle of project and in production. Understand the functionality of relevant process area and data that will be required to Build, Test and implementation.

Main Responsibilities include: Experimental procedures: Conducts experiments, accomplishes established milestones and summarizes data. Recommends options for other experiments. Presents data within team. Expertise and Problem Solving: Troubleshoots instrumentation or experiments; recognizes and assists with technical problems. Project Planning: Participates in planning project tasks; providing input to accomplish assigned tasks. Lab Safety: Participates in routine maintenance and lab safety. Documentation: Appropriately documents experimental procedures and results according to established guidelines. Quality: Responsible for implementing and maintaining the effectiveness of the quality system.

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Core responsibilities include: Identifies and controls Manufacturing process defects (scrap, nonconforming material, custom complaints)by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.; Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.;

Responsibilities as an R&D Engineer include: providing engineering support in the creation and development of new medical device products. Main responsibilities include: research, develop, and designs mechanica/electromechanical materials, components, assemblies, and processes. Conducts feasibility studies to verify capability and functionality. Developes new concepts from initial designs, etc.

Candidate will undertake the role of technician quality with some supervision. Daily responsibilities include: CAPA -Provides inputs to facilitate CAPA investigations as required. Investigates standard complaints. Identifies and prioritizes medical and reportable complaints. Monitor performance of manufacturing processes and implement required improvement activities. Manage Product and Process Improvements - Participate in Project and Process improvement activities. Quality/Compliance -Support manufacturing and testing operations as required; adhering to Good Manufacturing Practices and Good Laboratory Practices. etc.

The ideal candidate will have a strong background quantitative laboratory methods and mammalian cell culture. The position will require ability to generate precise, reliable and reproducible data in a timely manner. Demonstrate strong data interpretation skills, ability to troubleshoot experiments and instrumentation, ability to learn and understand new experimental techniques and be able to place data in proper scientific context by consulting and citing relevant literature.

This position will contribute to the development and validation of qualified reagents and generate data to support IVD products. Protocols and associated data may include immunohistochemistry (IHC), western blots, ELISA or other immunoassays, immunofluorescence or others as required. In addition, this position will be expected to complete scientific and technical tasks on aggressive timelines and to work as part of a team on varied tasks with changing priorities.

We are seeking a motivated individual for a research associate/senior research associate position that will specialize in antibody/protein engineering, gene sequencing, mammalian cell culture, and antibody expression/purification. This person will have good opportunity to experience many different areas in therapeutic antibody discovery, molecular biology and cell biology as an integral part of our Antibody Discovery and Engineering team. Responsibilities include: Sequence antibody variable (VH/VL) regions. Construct and validate gene and plasmid constructs. Express antibody/protein genes in mammalian cell systems. Purification of antibodies/proteins

The Product Development Technician is responsible for assisting in various Product Development projects. Duties include: maintaining, modifying and repairing H-Series and Radixact Radiation Delivery Systems; maintaining and repairing test and lab equipment; performing tests, measurements, and analysis; assisting Engineers with various Product Development tasks; selecting and purchasing supplies, components, and assemblies for maintaining and testing. Duties include: Maintain, test, troubleshoot and repair radiation delivery systems and associated bunker support instrumentation, in accordance with quality system requirements and associated manufacturing and service procedures. Manage inventory of spare and alternate parts necessary to maintain and reconfigure radiation delivery systems; procure replacement/new parts through supply chain, manufacturing, and/or service as-needed. Obtain required data sets; assist in analyzing and presenting findings.

Employee will carry out manufacturing practices in a cGMP biotechnical facility. The job involves the manual processing of porcine urinary bladders, which includes all aspects from collection of raw materials to packaging of the final product. Following training, work will be expected to be performed independently to a high degree of standard in biomaterial handling.

Responsibilities as an assistant manufacturing associate include: Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities.

The Analyst II, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

The position will design and coordinate experiments which leverage Adaptive’s unique platform to realize the company’s strategic objectives in hematology, immunology and oncology. Responsibilities include: Develop new assays for immune system profiling by next generation sequencing in collaboration with a team of other researchers. Develop new methods and technologies for project advancement including novel molecular biology methods, streamlined protocols, and automating tasks. Transfer developed methods and/or assays into SOPs for the development laboratory and/or production laboratory . Responsible for analyzing data and reporting findings to their supervisor

This position is responsible for supporting the Quality Management System (QMS) by working with production staff to ensure compliance with regulatory and internal process requirements. The position is accountable for the applications of industry quality requirements, standards, and tools to continually improve the quality systems established at Adaptive Biotechnologies. The position requires the ability to manage priorities from multiple projects and tasks while utilizing effective written and oral communication skills. This position will develop quality systems knowledge, and apply that knowledge through reasoning and judgment, to ensure an appropriate balance of quality, compliance, and business needs.

This position will provide extensive technical support for fulfilling contract requirements for immunological assays. Duties include: Assist in the development and qualification of new immunological assays including; but not limited to, the following:Multicolor-Flow Cytometry based assays, cytokines and other soluble biomarkers Multiplexing assays (Luminex, Aushon, MSD platforms), ELISA, ELISpot, and Neutralization Assays, among others. Responsible for organizing and ensuring efficient daily operation of the laboratory including: stocking laboratory with necessary reagents and other materials used for experiments and inventory of reagents and samples. This position will ensure the accuracy of record keeping of experimental conditions and results. Assist withdaily scientific duties in the laboratory in order to meet commercial and government contract obligations in a timely manner. Lab activities mayinvolve interaction with other functions and departments.

The responsibilities of this position are to assist with validation, feasibility, product development, and technical support of immunoassays.  Optimize components and performance, develop manufacturing procedures, transfer product/process to production, and perform necessary troubleshooting.  Work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Perform additional duties as assigned.

Under the direction of the Supervisor/Line Operator/Process Monitor, monitors material in order to maintain efficient flow of production. Operate hand or power trucks and other material handling equipment. Responsibilities include: Operate hand or power trucks and other material handling equipment to move materials throughout the unit. Change batteries on these material handling equipment. Delivers first (1st) pallet and subsequent pallets to staging area after verifying correct quantity of empty trays. Load product onto pallets, trays, baskets or conveyors, checking product identification to verify correct lot number, description, etc. Discard, reject and record information as needed. Sign and date the back of each tag once the pallet has been verified as having the correct amount of units and trays.

Reporting to Senior R&D Scientists, the Research Associate will be a part of our growing lab group that is responsible for generating and characterizing test materials to support manufacture process development and preclinical studies required to rapidly advance Affigen’s patient-specific monoclonal antibody therapeutics into the clinical-phase. In this role, the Research Associate is expected to take ownership of specific processes, assays or instrumentation (listed below) and act as the in-house subject matter expert in these functional areas. In addition, the Research Associate will be required to perform miscellaneous laboratory duties that may broadly traverse aspects of upstream, downstream, and analytical development and general research support. A successful candidate for this position will be performance-focused, detail-oriented, and capable of filling a multidisciplinary supporting role across multiple research and development activities through excellent communication, documentation and teamwork skills.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. PRINCIPAL RESPONSIBILTIES: Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Perform review of GMP documentation. Clean, assemble/disassemble, sterilize and operate primary process equipment.

As an active team member, you will support customers requesting hardware, software and applications assistance with Analytical Products and Solutions and route those customers whom you can't help to the appropriate groups. Our group's organizational goal is that as part of a world-class technical support group, we provide insights to customers at their very first contact. In order to be successful, our response needs to be quick and well-informed. Direct customer contact through phone/email channels; Service Request logging in the Agilent SAP Service CRM system and request routing to the appropriate technical team for handling.

The Engineer I/II in Upstream, Process Development will report directly to the Associate Director, Upstream Process Development at the Alachua, FL headquarters. Duties and responsibilities include: Plan, execute, and troubleshoot experiments for the optimization of upstream process steps in flasks and bioreactors for approved research plans. Optimize process parameters to increase virus yield from adherent & suspension cell lines. Responsible for scale up and manufacturing of viral vectors up to 200 L in bioreactor. Collect, analyze, record, and summarize data in the course of biologics production and processing Assist in maintaining laboratory supplies and equipment.

The QA Auditor I performs quality assurance duties at the assigned facility to prevent or eliminate defects in products for sterile filling operation or in final inspection and packaging operations. This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times. The QA Auditor reports directly to the QA Supervisor or Manager of Quality Operations. Duties include: Check the production lines to make sure the right product is issued to match batch record. Monitor the production processes and ensure consistency of procedures. • Review/approve raw materials or components for use in production, etc.

Hours are from 3PM-11:30PM. Under limited supervision and guidance of the Microbiology management team, the Microbiologist I is responsible for the following duties: Performs routine microbiological testing of products, raw materials, components and controlled environments according to site Standard Operating Procedures and compendial methods. Documents routine procedures following laboratory and company guidelines. Issues and revises GMP documents such as SOP’s, protocols/reports, testing monographs, data sheets, etc.

Responsibilities as a lab technician include: Receive, document,and prepare customer samples for testing, visual inspections of samples, test plans and reports, preforming method development and validations, coordination of the maintenance/operations of lab equipment.

Support Biomaterials by performing research and development engineering in materials design, printing, cellularization, and characterization of 3D printed scaffolds. Duties include: Assist in development and characterization of 3D printing under the direct supervision of project leaders/scientists. Assist materials development to optimize cellularization of printed objects. Build and maintain an understanding of current and emerging technologies within the field of biomaterials. Assist in performing analytical techniques for material development and characterization of 3D printed scaffolds. Follow prescribed laboratory methods and protocols under GLP/GMP-conditions; laboratory safety and use of protective equipment, and handling of biohazard materials including human or animal cells and tissues

The R&D Documentation Specialist will be a self-motivated individual with experience in authoring regulatory submission documents as well as creation and/or revisions of manufacturing documentation in accordance with GMP standards. He/she will have: (a) demonstrated experience with authoring, editing and controlling of manufacturing batch records (MBR) and process study protocols to support pharmaceutical development activities in Research and Development (b) hands-on experience with authoring and editing of CMC submission documents for ANDAs and/or NDAs (c) experience with creation and revisions of report templates, work instructions and/or standard operating procedures (SOPs) that support R&D activities (d) demonstrated flexibility to support multiple activities within the team/department (e) ability to work closely with cross-functional R&D, Technical Services and Operations team members and mange timelines (f) excellent writing and interpersonal skills.

The research associate will work in collaboration with the Microbiology, Immunology, and Systems Biology teams to aid in the characterization of organisms from the human microbiota through the execution of molecular biology assays and next-generation sequencing. General tasks will involve DNA extraction, sequencing library preparation, PCR and PCR-product verification, qPCR, sample organization, and coordination of tasks with the microbiology and immunology teams. Additionally, the research associate will support the preparation of samples for DNA sequencing at Vedanta and off-site.

You’re a front-end, back-end, or mobile software developer (including iOS and Windows Tablet) who likes to work on small teams in a fast-paced, agile environment, releasing features every four weeks. Help us design our solutions. Contribute to technical and functional design decisions, troubleshoot and provide technical product support, and be responsible for all aspects of the software development lifecycle. Drive all aspects of the software development cycle: design, implementation, tuning, testing, and monitoring of the functional areas that you will own, delivering products within the schedules and timelines.

The Vault Performance Engineering Team works within the Vault Development Team and participates in all phases of the SDLC.  In this role you will: Collaborate with Vault team members in Product Management, Engineering Management and Quality Assurance to help design and develop performance tests. Test new features pre-production to make sure they will scale and perform. Implement and execute load tests in JMeter. Use and update Python scripts for managing test systems.

We are seeking a new Automation Engineer to perform technical support on our lab instrumentation in our collaborative, high-energy work environment. S/he will be responsible for supporting the installation, modification, upgrade, and validation of lab equipment. Other key aspects of the role include: Support the development, test, and implementation of automated assays to increase the operational and throughput efficiencies in the laboratory in conjunction with technical leadership, regulatory managers, and professional leadership. Work as an independent contributor, working with cross functional teams focused on the development of automated clinical assays. Collaborate with the Bioinformatics and/or Information Technology (IT) team to integrate automated laboratory solution data outputs into departmental systems such as Laboratory Information Management Systems (LIMS)

Support Senior Project Manager on program critical project. Smooth is fast, and we need to go fast. Get to see what it takes to build a surgical robot. Key accountabilities include: Update Program Milestones in a PERT and Gantt charts. Place purchase requisitions. Create graphics to communicate plans, status, risk to the team and management.

As a Clinical Research Associate You Will: Manage and monitor clinical trial activity, including conduct of all monitoring visits at investigator sites and ensure all regulatory, ethics and training requirements are met. Responsible for ensuring that data will pass international quality assurance audits and regulatory inspections. Assist the project manager with the preparation of study tools, presentations and training material for investigator meetings, site qualification visits and site initiation visits as required. Work with the Management team in the development/revision and implementation of Standard Operating Procedures as required. Ensure compliance with appropriate Sponsor and Veristat SOP’s, 21CFR/ICH guidelines and applicable regulatory requirements. Ensure that all activities and interactions are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Sponsor and Veristat values. Required to travel 60-80% on average

Reporting to the Director of Quality Systems, as a Quality Engineer you will help develop, maintain and enforce all aspects of the quality system from the ground level. The quality engineer will work alongside and in parallel with the product development, manufacturing and regulatory teams, improving what we already have and imagining what we don’t. We are looking for talented quality engineers who are excited to lead and assist in the development and maintenance of Vicarious Surgical’s quality system. Support ISO, and MD certification process and compliance to FDA regulations by leading and/or assisting in the development, implementation, monitoring, enforcement and improvement of the quality system. Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

The CLS Coordinator is primarily responsible for coordination of designated operations and/or projects within the clinical laboratory. Responsibilities include: Demonstrate outstanding competency within all trained areas of the Clinical Laboratory Scientist. Evaluate and maintain inventory to ensure continuous service to the clients without creating over-stock. Assist Supervisor or Manager in overseeing the maintenance and record keeping for all instrumentation within the section.

The Project Manager function provides project support within a specialty R&D Engineering organization for new product implementation projects, improvement projects, and line extensions. The Project manager leads cross-functional team resources throughout the project life cycle and is accountable for meeting the agreed upon project scope, schedule, and budget within the directions of the Design Control Procedures. The Project Manager collaborates with internal cross functional resources and external partners (such as suppliers, vendors, testing labs and services) to properly staff their project and manage project risk.

The Graduate Program (GP) is intended to foster a pipeline of employees that deliver business critical results through outstanding performance, either as an individual contributor or as a future leader. As a member of the GP, you will have a unique opportunity to develop a broad knowledge base and skillset by working in one of the functional areas described below. GP participants will be paired with an mentor that will provide coaching and general guidance throughout the duration of the program, as well as a Functional Manager that will provide additional coaching, support and training. The functional manager will provide the goals and objectives for the position. The GP is intended to allow the graduate to learn the business and after 18 months within the program, potentially transition into another function and expand your career at Vyaire on candidate preference and organizational needs.

Working at the direction of the engineering leader, supports the implementation of production procedures to optimize manufacturing processes in a GMP environment. Assists with production process and/or scale-up. Assists manufacturing in problem solving with regards to equipment and systems. Collaborates with functions such as Process Development, Facilities, Quality, Supply Chain, etc. Oligonucleotide production process scale up by acting as a liaison between the Process Development and the Manufacturing teams. Support manufacturing operations and attend any equipment, process related technical issues. Troubleshoot production equipment and implement solutions.

Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management. Responsibilities include: Ensure Environmental Monitoring (EM) of the facility’s controlled areas is performed as required. Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation. Compile trending data for EM testing to support investigations. Audit personnel aseptic technique in controlled areas including during process simulations (media fills).

This is an entry level sales position that will require you to learn our products, market and industry. This role will initially support our Hand, Wrist, Elbow and Biologics portfolio and may grow into selling the shoulder portfolio. Through determination, networking and market data, this position will seek out surgeons to educate, promote, market and sell these products in assigned geographic location. You will: Conducts regular sales calls in person to develop customer relationships and follow up on leads in order to promote, market and sell products.Prospects for new accounts and seeks opportunities to increase sales with existing customers.Listens to customer needs and suggests appropriate products/solutions.

The Quality Inspector is responsible for performing inspection activities of both sterile and non-sterile products to ensure compliance to current specifications and procedures. Activities include Device History Record review, examination of supplier provided data, labeling and product acceptance, ensuring nonconforming product is identified, documented and segregated from acceptable product. Maintain control of quarantine area to ensure unintended use. This position is also responsible for handling and segregation of returned product.

Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision.

Perform all activities associated with supporting downstream production of our clinical and commercial operations in a GMP manufacturing setting. One must be flexible to work multiple shifts and weekends and/or overtime as needed. Perform downstream operations including: column chromatography, sterile filtration. and viral filtration. Assist manufacturing team in final drug product processes (Formulation and Aseptic Fill). Perform setup and operation of chromatography processing equipment according to established Standard Operating Procedures (SOP’s) and/or Master Production Records (MPR’s). This equipment may include but is not limited to AKTAprocess skids.

The Research Assistant assists with routine laboratory functions including diluting, labeling and dispensing of biological samples, reagent solution preparation, equipment repair, laboratory upkeep, maintains inventory of supplies, and various other responsibilities. These include: Design and conduct routine and atypical experiments. Maintains laboratories and equipment and performs minor repairs on equipment, with supervision. Maintains appropriate logs, records and study notebooks. Adheres to Good Laboratory Practice regulations and Sekisui XenoTech safety policies and procedures

Responsible for the design, development, and processing of implants and instruments. Work is expected to encompass both the development of new products and maintenance of existing products. Position will lead development aspects of the project as a core team member. Responsibilities include: Leads the development of new products and manufacturing processes. Identifies all tasks required to complete project assignments according to Design Control procedures. Prepares work plans outlining estimated manpower requirements and development costs. Recommends project budget and schedule to carry out programs on a timely basis.

Responsible for knowing, understanding, and supporting the STERIS Safety Philosophy.   Provides accurate and timely documentation and support to all Production Operations departments.  Analyze inventory reports to assure accurate reporting of labor and materials.  Compiles and reviews batch records for completeness. Identifies and corrects inaccuracies prior to forwarding to Quality Systems. Accountable for delays in release and meeting expectations for release times. Mentors plant employees and supervisors on documentation compliance and inventory accuracy.  Proper execution of assigned duties has a direct impact on the efficiencies of the plant and the final customer’s satisfaction.  Contributes to lean transformation by participating on rapid improvement implementation teams.  Other duties assigned by Supervisor to contribute to the support of all Production Operation departments.

The laboratory assistant will have opportunities to gain experience with meaningful data analysis, thinking critically & objectively, sample preparation, SOP optimization, and experimental design. Responsibilities include: Inventory, prepare, and maintain components for the sequencing platform. Maintain a clean, safe, and organized laboratory. Perform experiments on the sequencing platform as outlined by manager. Communicate results, status updates, and SOP deviations clearly and effectively to manager. Understand the purpose of each procedural step and how it affects downstream results.

Candidates will be involved in developing and optimizing the nanopore-based detection platform for our novel DNA sequencing technology, Sequencing by Expansion. The position primarily involves hands-on laboratory work as individual contributors and as a part of a development team. The Research Associate will work directly with founding Technical and Scientific Officers, Scientists, and Research Associates in a dynamic start-up biotech environment. Responsibilities include: Plan and execute complex projects, communicating schedule, implementation steps, and progress, Design and execute well-controlled experiments, Perform data analysis and protocol development, Identify problems and propose solutions

Focus on manufacturing floor support. Also, work with Operations/Process Development teams (assembly staff, engineers, and management) to ensure that production objectives are achieved with a constant drive for continuous improvement. These objectives include: aid in the efficient implementation and analysis of processes, process flow and equipment. Work with engineers on continuous improvement opportunities for facility layout and production flow optimization.

The Marketing Product Associate manages product line initiatives including, sales support and communication, marketing collateral development, market research, competitive intelligence, technical support and marketing plan development. Responsibilities include: Management of current marketing platforms that support and enable our sales team. Collaborate with internal teammates from across the organization on product management initiatives such as cost savings initiatives and product enhancements. Support implementation of Sage interventions at the hospital level through on site education and sales rep support.

Provide technical support for catheter-based medical device design and development at SurModics, Inc. Responsibilities include: Fabricate device prototype components and assemblies to assist in the design and development of new catheter-based products. Refine processes in the development of new products while working with the engineering team. Assist with developing and troubleshooting manufacturing processes and equipment, including fixture design and equipment qualifications. Provide technical support for catheter-based medical device design and development at SurModics, Inc. Responsibilities include: Fabricate device prototype components and assemblies to assist in the design and development of new catheter-based products. Refine processes in the development of new products while working with the engineering team. Assist with developing and troubleshooting manufacturing processes and equipment, including fixture design and equipment qualifications. Provide technical support for catheter-based medical device design and development at SurModics, Inc. Responsibilities include: Fabricate device prototype components and assemblies to assist in the design and development of new catheter-based products. Refine processes in the development of new products while working with the engineering team. Assist with developing and troubleshooting manufacturing processes and equipment, including fixture design and equipment qualifications. Provide technical support for catheter-based medical device design and development at SurModics, Inc. Responsibilities include: Fabricate device prototype components and assemblies to assist in the design and development of new catheter-based products. Refine processes in the development of new products while working with the engineering team. Assist with developing and troubleshooting manufacturing processes and equipment, including fixture design and equipment qualifications.

Your main responsibilities will be to perform functions in support of Product Application Scientist(s) and other individuals as needed, perform common laboratory testing (including ELISA) using established protocols, prepare buffers and other chemical solutions as needed and use proper personal protective equipment (PPE) and good aseptic technique to handle biological (including human) samples. On a day-to-day basis, you will be expected tosuggest, plan and carry out studies with guidance of supervisor, record data for evaluation, analyze results with guidance of supervisor and assist other lab personnel as needed, maintain organized records of studies performed, and other duties and responsibilities as assigned.

Duties as a chemical synthesis associate include: Manufacture active pharmaceutical ingredients, drug products, and medical devices. Ensure compliance with the quality system, regulations, and safety procedures. Maintain instrumentation and facilities in proper operating conditions and cleanliness. Manufacture pilot stage liquid medical device products. Perform analytical testing for manufacturing, qualification, and validation activities.

The Biostatistician performs the data analysis with supervision for assigned clinical studies. Works closely with the clinical team, project Sponsor, clinical data manager, other statisticians and programmers to analyze and present the data based on Sponsor specifications. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and project Sponsors, executes quality assurance procedures on work produced by others and ensures statistical analysis is being done according to specifications.

We are seeking a highly motivated and responsible technician to join our team under a full time or part-time contract. Responsibilities would include: Preparation of biological reagents to support cell culture. Sterilization of culture vessels and associated components. Maintenance and troubleshooting of automation equipment. Must be available for limited and compensated work on weekends.

The Animal Care Technician 1 will be responsible for providing general support to animal care technicians in a barrier by completing tasks related to supply import, export, general barrier cleaning and basic animal husbandry. Responsibilities include: Ensuring high standards of animal welfare are met. Reporting inhumane treatment regarding animal care, use or abuse. Documenting work performed according to SOP’s. Ordering supplies, loading and unloading containers or supply cylinders.

Objectives in this position include: Perform supportive activities for general laboratory operations, laboratory equipment preventative maintenance, sample pull, receipt and delivery. Support the Technical Operations group by performing routine laboratory tasks to facilitate the experiments performed by the associates and scientists. Assist in the general organization of the laboratory and perform some basic administrative tasks such as photocopying/scanning and organizing documents and files.

The candidate will perform complex research assignments and will be responsible for the discovery and engineering of therapeutic biologics including antibodies, fusions and other platforms. The candidate will communicate results within the Biotherapeutic Engineering team and with cross functional project team members. Responsibilities include: Under minimal supervision, execute discovery and lead optimization projects using display platform technologies with high quality and efficiency. Handle large data sets and analyze the data. Identify hits based on affinity, specificity and potency. Isolate DNA/RNA, analyzing sequencing data. Apply knowledge of antibody function and characterization, conduct repertoire analysis, and V region classification

Candidate will work closely will with firmware engineers to execute and write test cases for qualifying new firmware and software builds. Candidate will perform root cause analysis on test failures and write detailed bug reports. Create test scripts for automation framework for unit, integration, and life cycle test, preferably in Python, is a plus. Experience in ARM, RTOS, I2c, SPI, UART or CAN preferred.

The program consists of four six month rotations in multiple areas where this core process is utilized and accompanied by a robust technical and leadership curriculum. At the conclusion of the two year program, participants will be candidates for leading technical or management roles across the company in this core manufacturing process. Responsibilities may include: Shadowing, assisting and learning from the global leaders of the Compounding Extrusion, and Finishing Center of Excellence (CoE) and the Digital Factory Center of Excellence (CoE). Learning how to connect processes to our digital factory network, extract digital process information, and build improvement plans to act on what the data shows. Learning the Wire and Tubing Extrusion core manufacturing process and being an advocate of sharing best practices from one plant to another.

TE Connectivity's Manufacturing/Production Teams transform raw materials into finished goods and ensure component flow. They perform changeovers and setups according to production schedule, perform quality checks according to established processes and document the results as required by our quality procedures. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following TE Connectivity's EH&S policies and procedures.

Provide accurate and timely testing of raw materials, finished product and/or stability samples as assigned. Ensure the safety and reliability of products produced in compliance with quality and regulatory requirements. Essential responsibilities include: Perform quality control testing on raw materials, finished product, pre-approval and commercial stability samples as assigned by the supervisor. Wet and Physical chemistry techniques including but not limited to: Karl Fisher, Viscosity, Microscopy, pH, specific gravity, IR, Specific Rotation and wet chemistry.

We are looking for a Jr. Clinical Trials Data Analyst who will work with our clinical and computational biology team on reports for clinical and research use. Responsibilities include: Works collaboratively within cross-functional teams at Tempus (including but not limited to scientists, pathologists, product development) to create customized clinical reports. Analyze patient clinical records and molecular testing results to identify potential clinical trials. Perform critical quality control functions in clinical report workflow. Support ongoing and future projects within the team.

As a clinical molecular technologist, you will be responsible for: Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Utilize automation and robotics to standardize the discovery pipeline from sample acquisition to sequencing output. Maintain quality metrics and data generation for next-generation sequencing platforms. Work to maintain CLIA/CAP compliance in a novel field

The Quality Analyst I (QA Specialist: Complaint Investigation Support) is responsible for the general oversight of Customer Complaints, Complaint Deviations & CAPAs, and Documentation Change Request/Revision (Protocols, SOPs, Lists, Forms, APR attachments, etc.) associated with departmental procedures. Essential duties include: Receive complaints through the designated software system in a timely manner. In accordance with applicable standard operating procedures (SOPs) categorize the complaint, make appropriate contact with the complainant to obtain information required to properly investigate the complaint and complete the applicable fields in the system to document the activities. Request the return of samples, when required, and determine the necessary actions required to thoroughly investigate the complaint, including but not limited to documenting the information received through interviews with parties impacted by the complaint submission, documenting the information received from submitted documentation and field samples, submitting samples to the Quality Control laboratory for analysis, sending samples out to outside vendors for analysis, requesting information for various departments to support the complaint investigation and coordinating the complaint investigation with impacted departments, including other Actavis sites and contract vendors.

Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Performs stability testing for Finished products. Performs maintenance and calibration of analytical instruments. Duties include: Operates general analytical instruments during the testing of finished products using HPLC, UPLC, GC-FID, UV-VIS, FTIR, automatic titrators, Dissolution Apparatus, particle size analyzer, Instron, Densitometer, Rheometer, viscometer (LV/RV/Cone and Plate), pH meter and analytical balance. Prepares standard, sample, and buffer solutions as required by test methods and performs all necessary calculations associated. Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs. Cleans, maintains and calibrates laboratory equipment to ensure compliance with current Good Manufacturing Procedures (cGMP).

Responsible for Operations fo GLP Fill-Finish manufacturing facility for parental DP's. Perform all activities supporting the production of sterile DP, including but not limited to: operation of the filling line, filter integrity testing, preparation of components and supplies including use of the autoclave, documentation (batch records, logbooks, etc.), routine in-process analytical testing, visual inspection, and cleaning of critical process equipment. Support supply chain logistics to enable early Toxicology and Clinical DP manufacturing including materials movement, change controls, relevant documentation readiness through interface with internal or external CMO sites.

Responsible for reviewing documentation for batches that are manufactured and packaged. Assure compliance with cGMP before being released for further processing, packaging or commercial market. Review completed manufacturing and packaging documents, as well as laboratory test specification sheets. Ensure all pertinent information is compiled, reviewed and approved prior to any product disposition. Identifies improvements/new procedures/ compliance gaps based on applicable regulations. Assign QA status (Release/Reject/Quarantine/Impound) to work-in-process and finished product. Investigates and troubleshoots all routine problems which occur during work assignments.

The Associate Process Development Scientist will perform studies to develop and optimize the manufacturing process of gene-modified cellular products to support the company’s development programs. Under the supervision of Sr. Scientist: Perform development studies including optimization of cell isolation, cell culture, cell transduction and cell cryopreservation processes. Evaluate innovative manufacturing & analytical technologies for engineered T cell manufacturing to improve process efficiency. Author technical and scientific documents including but not limited to SOPs, Master Batch Records, study protocols and reports.

Under direct supervision, perform sample analysis, data and document review, and method development and validation. Essential duties include: Develop and validate analytical methods to current ICH and USP guidelines. Accurately analyze formulation, drug, or product samples and assist other departments in analyzing samples as requested. Perform routine sample analyses in support of GLP or R&D stability protocols. Assist the Quality Control laboratory in troubleshooting method issues. Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies. Write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to governmental agencies.

The successful candidate will work hand in hand with our study directors, quality assurance and sponsors/clients to ensure all medical device preparation aspects are performed per scientific and regulatory standards. Responsibilities include: Review the nature and composition of medical devices and determine sample requirements for testing. Medical devices are prepared for testing using geometrical calculations and therefore skill in routine mathematic principles is required.

We have a unique opportunity for an entry level to intermediate Scientist to perform laboratory analyses in the testing of raw materials for release, in process (IP), finished products (FP) during process validation and stability (ST) samples of test batches and to carry out laboratory work to support method validation activities. This position is located at our Monmouth Junction, NJ facility. Responsibilities include: Operates general analytical instruments during raw material, in process and finished product testing such as HPLC, GC, UV/Vis, automatic titration, IR, AA, TLC and dissolution apparatus. Performs wet chemistry tests such as LOD, pH, and titration; prepares standard and sample solutions as required by the test methods; and performs all necessary calculations associated with the test analyses.

As an analyst, you will be part of teams that work across the entire spectrum of our offerings and our clients. We are working with some of the most innovative companies, who are providing the latest in critically needed therapies.

North suburban Chicago contract pharmaceutical manufacturing company needs a Production Chemist to operate and clean equipment used in the production of bulk chemicals. Responsibilities include: Operation of all plant equipment. Cleaning of all plant equipment. Interaction with clients and sales team. Directing operators and technician

REMD Biotherapeutics is seeking exceptionally motivated scientists with strong background and proven track records in molecular and cellular biology to join our Drug Discovery team located in Camarillo, CA. Responsibilities in this role include: Design and perform cutting-edge research that utilizes genetic engineering to create novel therapeutic proteins and the cell-based assays needed to assess their biological activity. Work independently and collaboratively to develop and execute novel physical and biological assays required to evaluate new antibody-derived therapeutic proteins. Organize, analyze and present complex data generated on novel proteins in a scientifically rigorous manner for the purpose of advancing clinical candidates.

Acts as the primary liaison between Clinical Program Leads and Clinical Research Organizations (CROs). Supports Clinical Program Leads in operational and logistical tasks of pre-start up, start up and start up activities related to clinical trials performed according to regulatory, GCP ICH requirements, operational best practices and quality standards (ICH GCP / country and local requirements / company SOPs). Provide support across the Clinical department and partner with Clinical Program Leads and Medical Affairs on specific tasks involved in support of running clinical trials, from start- up through completion.

The Business Development Associate will support the Business Development team in their efforts to achieve territory and corporate sales goals as well as assist in creating and executing a successful sales strategy. The ideal candidate will be adept at client-specific research and will provide active support in generating business leads. Responsibilities include: Perform outreach (phone, mail, email) to potential leads to generate interest in Rho’s services with provided text and scripts. Schedule telephone, face-to-face, and web meeting appointments for Rho business development professionals. Ensure a high level of communication and customer service

The two-year tech rotational program at Roivant begins summer 2019 and will give you experience across a variety of functions within Roivant and our subsidiary companies. Throughout our businesses, analysts will look for ways to integrate modern technology and will have the opportunity to develop Roivant’s innovative health and pharmaceutical companies in their early stages. As an analyst, you will have the opportunity to rotate through the following teams: Digital innovation, Digital Product, Devops, Data Architecture

We're seeking a Research Associate to perform experiments, immunoassays and other technical procedures in addition to writing research protocol and reporting experimental data. Essential duties: • Conduct routine laboratory procedures, assays, and experiments according to protocols. • Complete training and submit records on established protocols, assays and procedures. • Collect, evaluate, interpret and document research data according to scientific objectives. • Log, store and maintain samples with accurate records for research and production projects. • Maintain laboratory to ensure smooth operation and timely lab activities.We're seeking a Research Associate to perform experiments, immunoassays and other technical procedures in addition to writing research protocol and reporting experimental data. Essential duties: • Conduct routine laboratory procedures, assays, and experiments according to protocols. • Complete training and submit records on established protocols, assays and procedures. • Collect, evaluate, interpret and document research data according to scientific objectives. • Log, store and maintain samples with accurate records for research and production projects. • Maintain laboratory to ensure smooth operation and timely lab activities.We're seeking a Research Associate to perform experiments, immunoassays and other technical procedures in addition to writing research protocol and reporting experimental data. Essential duties: • Conduct routine laboratory procedures, assays, and experiments according to protocols. • Complete training and submit records on established protocols, assays and procedures. • Collect, evaluate, interpret and document research data according to scientific objectives. • Log, store and maintain samples with accurate records for research and production projects. • Maintain laboratory to ensure smooth operation and timely lab activities.We're seeking a Research Associate to perform experiments, immunoassays and other technical procedures in addition to writing research protocol and reporting experimental data. Essential duties: • Conduct routine laboratory procedures, assays, and experiments according to protocols. • Complete training and submit records on established protocols, assays and procedures. • Collect, evaluate, interpret and document research data according to scientific objectives. • Log, store and maintain samples with accurate records for research and production projects. • Maintain laboratory to ensure smo

The Associate I, Oligonucleotide Chemistry will work on a rapidly growing team focused on supporting internal Research and Discovery, Analytical Development, Pre-clinical, and Toxicology groups. This role will perform high throughput synthesis, purification, and isolation of Sarepta’s phosphorodiamidate morpholino oligomers (PMOs). The Research Manufacturing Oligonucleotide Chemistry group synthesizes PMOs for lead-candidate screening, Analytical standards, and commercialization support.

Follows standard operating procedures and maintains recordkeeping pertaining to equipment operation, animal and supply inventories in accordance with federal and state guidelines and regulations. Handle, transfer, and distribute mice, supplies and waste as needed to and from work area(s). Coordinate with vendors and supervisors on operational, administrative and technical responsibilities . Monitor the daily health and welfare of the animals according to IACUC guidelines

This position is located within the Quality Control department and is responsible for performing potency/binding assays (cellular bioassays and ELISA) and other related Quality Control methods for release and stability testing. Additional responsibilities include: preparation of solutions for potency assays, perform routine preventative maintenance on lab equipment, lab stocking, and performing cell passages.

The BioProcess Development Department at Seattle Genetics is seeking a Research Associate to participate in the purification development efforts to support process development for our antibody and antibody-drug conjugate programs. Responsibilities include: Perform bench-scale chromatography and filtration development and characterization studies. Conduct platform fit assessments for early phase programs.

Responsible for receipt, storage, and delivery of laboratory supplies & equipment, office supplies and other products such as break room supplies. Shipping & Receiving Associates I must demonstrate meticulous attention to detail, flexibility and a willingness to perform a wide variety of tasks while adhering to defined procedures. The position will work directly with the Purchasing, Research & Development, and Finance departments to accurately track, record, deliver and maintain the correct amount of supplies and equipment to the correct locations at all times.

A Quality Control Technician works independently to provide quality control support of any area assigned where Sedia Biosciences is responsible for adhering to current Good Manufacturing Practices (cGMPs) for adherence to FDA regulations and applicable ISO standards including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review/disposition, and new product design review and transfer activities. Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.

The ideal candidate will assist in the development, expression, and scale up recombinant proteins from bacterial or other vectors, purify proteins and perform subsequent validation and quality assessments. The selected candidate will have demonstrated experience in most of the technical skillsets and be able to work in a small group of individuals, in a highly cross-functional environment.

The Research Associate will be responsible for designing, executing and interpreting experiments and analytical procedures under general supervision. Initiates, directs and executes pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the-art principles and theories. May participate in development of patent applications. Interfaces with various departments.

This is a multi-discipline position with 3 primary components: specimen accessioning, sample splitting/sorting and data entry. Prepares laboratory specimens for designated departments/locations prior to laboratory analysis and testing and routes specimens by type to various staging areas. Performs all paperwork, technical and non-technical procedures required to process and submit specimens. Assigns specific computer generated identification numbers, checks for accuracy and records all items processed. Operates data entry terminals and automated data systems, follows standard sequences/coding when entering data and corrects, edits, and/or verifies data entered into automated systems. Must be able to perform eSIS audits to resolve any outstanding problems. 3rd shift

Prepares laboratory specimens for designated departments/locations prior to laboratory analysis and testing. Unpacks specimens from branches or ports and routes specimens by type to various staging areas. Prepares all specimens received for testing in designated laboratory departments or locations such as staging of specimens, centrifuge, separate serum, and blood smears. Aliquots sample for departments. Prepares excess specimen samples for storage and resolves and document problem specimens. 2nd shift

Performs all paperwork, technical, and non-technical procedures required to process and submit specimens. Assigns specific computer generated identification numbers, checks for accuracy, and records all items processed. Forwards accessioned specimens to designated laboratory location(s); and locating and correcting any discrepancies. Learns and keeps familiar with lab procedures and location of stored specimens. Locates specimens and pulls from various departments as requested.

The candidate will be a key member of an entry level, interactive technical service team that acts as the front line of communications between customers and our technical service specialists.  This team is focused on providing best-in-class customer support via telephone, email and internet.  The candidate is responsible for fielding basic technical inquiries on MilliporeSigma's products and navigating more advanced technical inquiries to the appropriate specialist within the organization. Our customer base includes Pharmaceutical and Biotech companies, Universities, Hospitals and Government agencies.  Professional communication and schedule flexibility are imperative.

Under close supervision, the Production Associate participates in entry-level production duties such as filling, labeling, packaging, shipping and other duties as assigned in a laboratory/manufacturing environment. Essential duties include: filling, labeling, packaging, etc.

The Protein Science / Buffer-media prep and QC group is a core function of the Protein and Cell Sciences (PCS) department that supports both early and late stage discovery projects and seeking a QC Research Associate. Responsible for small to large scale media and buffer production, as well as QC analytics supporting GLP tox drug substance production. Responsible for media / buffer preparation, equipment maintenance and calibration, data analysis, electronic lab notebook and batch record documentation. Responsible for media and buffer preparation to meet GLP tox protein production and reference run schedules, which includes raw material and chemical procurement and inventory control.

Siolta Therapeutics is seeking a highly ­motivated and talented technical staff scientist to provide support for the company’s therapeutic development program focused on prevention/treatment of airway inflammation through manipulation of the gut microbiome. The successful candidate will work closely with other team members on preclinical studies of a rationally designed microbial therapeutic. The successful candidate will be technically proficient in microbial culture and molecular techniques.

Position functions include: Develops and works with area teams to implement continuous quality improvement programs/productivity projects which may include: vendor certification for ship to stock; design of experiments to identify and thus control process variables; evaluation of lot inspection and initiation of process audit activities; and installation of statistical and non-statistical process controls; simplification of forms. Lead the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products. Develops and administers an inspection, test, and/or audit program to assure that incoming, in-process, and finished product meets functional specifications and quality standards.

A Manufacturing Associate who will be responsible for manufacturing CAR-T cells per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Responsibilities include: Weigh and measures in-process materials to ensure proper quantities are added/removed. Adheres to the production schedule ensuring on-time, internal production logistics.

We are seeking a highly motivated individual to join our analytical development and quality control team. The position offers a unique opportunity for the candidate to work on a variety of projects using various techniques to assess analytes. The position’s focus will be on therapeutic protein drugs development with analytical methods development and validation, characterization and release testing of drug substance and drug product, and stability testing in a GMP- and GLP-compliant environment.

Spherotech, Inc. seeks a college graduate for a Quality Control Associate opening. Duties include final product inspection, documentation, Quality Control testing etc. This

Under the direct supervision of the Operations Manager, the Patient Access Specialist is responsible for facilitating patient access services by managing incoming calls, assisting clinic customers at first point of contact, and streamlining clinic-wide communications. Also responsible for the daily work schedule for a group of physicians/staff by answering the phones, obtaining records, verifying patient information, scheduling appointments, entering charges and collecting payments.

We are seeking to add a Regulatory Affairs Engineer II that will be responsible for supporting all Regulatory affairs for medical devices and hearing related products. This position will work with various departments across the organization such as Sales and Marketing to the Product Development group with guidance from senior regulatory personnel throughout the product life cycle. You would support activities that keeps Starkey current with changes to medical device regulations. This position is also responsible for creating and maintaining the technical files for all medical devices and hearing related products.

Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation. Review and approve Device Master Record documentation for new product design and maintenance, including: bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator’s manuals. Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary. Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities.

This role is a hands on statistical programmer supporting study and asset teams in the delivery of less complex statistical programming deliverables. Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures, and qc work for which they are responsible. Ensures adherence to high quality programming standards in their daily work. Accountable for their assigned work in the programming space supporting the programming leads for a particular study or asset deliverable.

Responsible for continuous product and process quality improvements. Conducts investigations into NCs and CAPAs stemming from the products in the field. Leads root cause activities and Identifies potential failure modes and risks and resolves customer issues appropriately.  Knows and applies the fundamental concepts, practices, and procedures of the general Quality and Regulatory post-market environment. Responsibilities include: Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to identify opportunities for quality improvements. Communicate with Customers, members of Field Service and Sales organizations to gather information necessary to carry out investigations.

PolarityTE is seeking a motivated, responsible, and self-sufficient individual to help support the everyday tasks of the Clinical Trials department. Responsibilities will span multiple trials and indications. Key responsibilities include: Manage the organization of trial files and critical documents. Support clinical trials team with shipments, equipment tracking and management, and supply inventory. Maintain clinical trial metrics and patient enrollment activities for weekly and monthly meetings. etc.

The Development Associate will be a key member of a dynamic team that develops and implements characterization strategies to support and enable process and clinical development of gene-engineered cell products. This is a lab-based position that will involve hands-on development of clinical manufacturing processes for selecting, gene-modifying and growing T cell subsets. This position will interface with our Research and Development team as well as with outside Contract Manufacturing Organizations. The ideal candidate will be skilled in T cell culture techniques, flow cytometry and have experience working in or supporting cGMP manufacturing projects. The candidate will have good oral and written communication skills, and will work with minimal supervision to design experiments, manage projects, collect data, and prepare reports.

Responsibilities include: Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

Responsibilities as a Entry Level Scientist include: Possesses an understanding of laboratory procedures and under general supervision can conduct complex analysis. Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

Responsibilities as a assistant scientist include: Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

Responsibilities include: Provdies regulatory expertise/guidance for development and submission of US labeling components. Controls consistency of US labeling content through alignmnet with the core documents across product families and with all applicable best practicies. Must have a basic understanding of the drug development process and knowledge of the pertaining regulations

As a clinical trials specialist, you are the primary point of contact/liaison for the sites. Sponsor internal stakeholders during study life cycle. Preform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol. In addition, you will create and distribute meeting agendas and take meeting minutes during internal and sponsor calls, roll out training plans to team members and provide access to project systems.

The Lab Associate is part of the operational team within the sample preparation alb. The Lab Associate ensure the appropriate collection, processing, storage and shipment of samples. Daily tasks may inolve maintenance of equipment, processing and shipment of samples. The Lab Associate is part of the study team that is responsible for the execution of the study. \

The Research Associate, Cell Therapy Bioanalytics works within the Cell Therapy Development Team and participates in providing bioanalytical support for Cell Therapy Process Development projects. The position will contribute to Bioanalytics development efforts for CART-cell projects by providing sample preparation and analysis in a timely manner. This position is lab-based and will share facilities and resources with the Cell Therapy teams. Daily responsibilities include: Execute bioanalytical methods for in-process sample analysis and cell product testing, Analyze generated data according to established SOPs and report results of analysis to Cell Therapy Team Leaders in a timely manner, Coordinate with Scientists, Research Assistants, and Research Associates to plan and carry out experiments for developing T Cell Therapies.

You will collaborate across a broad portfolio of sophisticated health economic and health policy research projects. You will perform a wide range of activities including: literature reviews; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader.

As an Associate Research Scientist/Research Scientist, you will responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. You will have a basic familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and will execute a wide range of activities including: project management; literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader.

Day to day tasks as a technologist include: Performing simple and complex processing of blood and body fluids (routine and non-routine procedures). Setting up instrumentation and running calibration samples. Running quality control samples, clinical samples and generating data. Work with QA to perform good documentation and ensure the lab is operating under CLIA, GLP and GCP standards.

As a medicinal chemist you will apply state of the art synthetic chemistry, structural and computational approaches to discover and synthesize novel medicines for a variety of diseases including immuno-oncology, inflammation and neurodegenerative diseases.  Research Scientist will independently plan and implement efficient synthetic routes for target compounds and apply state of the art purification and characterization techniques, conduct research with the drug discovery team to develop SAR, analyze the data and write laboratory reports. Position provides opportunities to grow, write papers and patents, and present data at internal, national and international meetings.

Responsibilities as a compounding technician include: Mixing chemicals/ingredients and operating all mixing related equipment in a way that meets safety, quality/compliance and productivity objectives. Following and enforcing safety rules, regulations and procedures. Checking all raw materials against MBR ingredients list, recognizes errors and notifies lead personnel as required. Compound/blend all routine formulations and follow MBR as written.

Essential duties include: Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.). Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements. Manages and tracks Investigational Product supplies for study centers; receives and prepares requests, ships and returns Investigational Product supplies.

We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities include: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms.

This position will also be responsible for providing escort for equipment qualification with vendors, witnessing controlled substance receiving and dispensing, coordinating laboratory waste disposal and pickup, as well as performing and/or facilitating equipment calibrations. This role may perform other related assignments and duties as required. This position will primarily provide hands on support in manufacturing finished product dosage forms – tablets, capsules, liquids and semi-solids. This position will be responsible for equipment set up, product manufacturing and cleaning as per EHS, DEA and FDA regulations. In addition to assisting the product development scientists in manufacturing finished product prototypes, general support of the laboratory is required. Support activities will include managing inventories for raw materials, personal protection equipment, supplies, etc.

The Shift Process Engineer performs all manufacturing tasks required for the safe production of active pharmaceutical ingredients in compliance with FDA, DEA, OSHA, Federal, State, and Local regulations. The primary objective of this position is to ensure that all manufacturing operations are conducted in a safe manner with a high regard for all applicable cGMP’s and DEA requirements. Working flexibility across a broad range of chemical operations and participation on self-managed work teams is required. Training for and participation on Emergency Response Team is required. Availability for overtime and shift work (including rotating shifts and seven-day operation) is also required.

The Technical Associate in Kit Assembly comprehends and performs assigned manual production tasks according to established standard operating procedures. Responsible for Manual production and assembly procedures in compliance with relevant regulations and Standard Operation Procedures. Adhere to and accurately complete all production-related documentation. Responsible for set up, trouble shooting and operation of production related equipment within the assembly area.

Whether their focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides our clients with a full range of services to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies. An Associate Scientist in our DMPK department will be a fully-supervised trainee, responsible for formulations, and sample processing and analysis to support preclinical drug discovery and development.

As a Production Assistant 1, you will be responsible for the processing of raw biological material for use in product manufacturing. You will also perform maintenance and cleaning of production equipment and containers to ensure safety and compliance, as well as completing required paperwork.

The Packaging Operator is responsible for providing the Technical and Operational Skills needed to deliver world class results in the key areas of Line Efficiencies, Quality, and Cost while meeting our high standards of Safety, Customer Service, and Teamwork. Key responsibilities include: Operation of Packaging Line and related equipment including startup, clearing jams, manual operations and shutdown. Follows all applicable waste, scrap reduction and recycling guidelines. Assists in changeovers, wash outs and preventative maintenance.

This position has responsibility and authority for delivering top quality firmware solution required to meet overall radiotherapy product requirements.  This includes: Prototype, design, implement, test, debug and maintain firmware (device drivers, BSPs and Hardware Abstraction Layer library) that serve as the bridge between hardware resources and application software. Participate in completing test cases, conduct embedded systems verification and generating test reports to support a 510(k) submission and FDA clearance. Participate in cross-functional project teams with scientists, technical support and other engineers to resolve software issues.

Weekend and On-Call Position. Responsibilities and duties include: Process and key-in prescriptions with accuracy, attention to detail, and efficiency. Correctly input sensitive prescription information into computer system, dispense correct medication, and verify information before releasing prescriptions. Demonstrate knowledge of Third Party insurances and billing procedures. Proactively partner with the Pharmacy, Operations and Engineering teams to address issues and achieve high quality and throughput in fast-growing, technology-empowered pharmacy.

Initiates, maintains, and compiles records associated with ordering, receiving, storing, issuing, and shipping materials, supplies, and equipment by performing the following duties. Compares nomenclature, stock numbers, and other listed information on packing slips to verify the accuracy of purchase orders and shipping orders. Compiles data from sources such as contracts, purchase orders, invoices, requisitions, and accounting reports and writes, types, or enters information into computer to maintain inventory, purchasing, shipping, and other records. Verifies inventory computations against physical count of stock and adjusts errors and reports documenting reasons for discrepancies with proposed corrective action. etc.

This position will assist production related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida). Responsibilities include: Perform and/or assist with downstream related activities including Chromatography purification, Centrifugation and Ultracentrifugation, Ultrafiltration/Diafiltration, Viral Clearance. Draft Standard Operation Procedures, Change Control, Deviations. Properly disinfect and stage materials into production rooms before the production campaigns. Assist with equipment ordering, installation, qualification and routine maintenance. Perform activities to support production campaign such as preparation of tubing assemblies, autoclave, material request and transfer into production room.

The Research Scientist I assists and participates in biomedical, pre-clinical and clinical research and development projects, experiments, and investigations relevant to the Company’s product strategy or services, disseminating findings through internal reports. This is an entry level research position. Job duties include: Support the design and implementation of research and/or engineering development projects. This may include but is not limited to, support of in-vivo (animal) and ex-vivo testing. Collaborate with other functional groups including product development, clinical and regulatory to fulfill project deliverables. Assist with the execution of clinical research investigations and product evaluations. Create and maintain files related to the pre-clinical and clinical activities.

The Endoscope Technician must understand and accept the responsibility to ensure the safety of all Olympus products that are repaired by strictly following established processes and procedures. Under the direction of the Manager, the incumbent shall evaluate, troubleshoot, disassemble, assemble, repair and inspect Endoscopes, Electronics, or Microscopy products to meet company product standards and ensure full and proper functioning of the repaired product. Level I Technician: Assignments are semi-routine difficulty level. Requires daily supervision, detailed instruction on new assignments.

As a Field Service Engineer I working on the Field Service team, you will be empowered and inspired to do your best work. You will contribute to our mission by providing our customers with the best support and repair solutions, assisting our field sales teams with installations and maintenance of equipment and contributing to the growth of the division. Duties will incude: Performing new equipment installations, upgrades, post installation testing, troubleshooting and all other aspects of technical support for all endoscope, mechanical, electronic, video, computer, LAN and network products. Troubleshooting, diagnosing, and repairing the entire line of medical electronic, video, computer and network products on customer premises, at Olympus repair facilities, and when necessary via telephone. Escalating support issues when customer satisfaction is jeopardized and report all product non-conformance and safety concerns.

Perform various chromatography assays including reverse phase, size exclusion, affinity and ion exchange chromatography. Participate in analytical studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development. Conducts routine tasks and sample analyses to support process development. Executes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.

Provides Metrology support in a laboratory environment by following standard practices. Performs laboratory instrument calibrations, qualifications, preventative maintenance, and repairs as assigned. Makes detailed observations and reviews, documents, and communicates test results. Essential functions include: Executes test methods for instrumentation including, but not limited to; LC, GC, dissolution, spectroscopy, pH meters, thermometers, and balances. Recognizes and reports out-of-specification or unexpected results and non-routine instrument mechanical performance problems. Supports routine instrument preventative maintenance and troubleshoots unplanned mechanical repairs.

Responsibilities include: Involves multiple de novo R/D projects for antibodyand assay products development.Performsvalidation tests on variant sera or antibody samples. Participates other duties such as antibody production, purification and conjugation. Records experiment procedure and results in notebooks and computer accurately. etc

Entry level engineering position responsible for supporting projects lead by more senior engineers. Responsibilities include: developing CAD models/drawings, authoring test protocols and reports, performs product testing, etc.

The Analytical Chemist is responsible for testing of raw materials, in-process materials, and finished products to support release and stability programs. Perform laboratory tests such as sample extractions, set up and execution of chromatographic methods (HPLC and GC), and dissolution testing. Develops and executes UV, IR and PSD measurements and wet techniques as applied in the Pharmaceutical Analysis/Testing of products and excipients. Executes components of method validation and method transfer projects.

The Package Testing Technician is an integral part of the AMRI team, contributing to our success by performing data review, auditing laboratories, investigation/corrective action follow-up, and reviewing written procedures. Responsibilities include: Independently perform duties, both routine and non-routine, completed in a reliable and accurate manner. Endure the integrity of the final report of analysis being in compliance with all regulatory and company standards. Primary QA reviewer of all analytical data generated in the laboratory and performs weekly review of all logbooks, temperature tracking documents and any other related logs maintained in the laboratory.

The Research Scientist I is an integral part of the AMRI team, contributing to our success by performing laboratory experiments and instrumental testing in the Analytical Development group. Responsibilities include: Conduct laboratory experiments as part of development and validation of solid-state chemistry analytical methods to support drug development processes, including but not limited to preparation of solid-state mixtures and studies of solid-state attributes of materials. Perform routine instrumental testing according to study design and under the guidance of the project leader.

The Quality Control Microbiologist performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. Some responsibilities include: Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product. Perform environmental monitoring of the clean rooms (under ISO and EU specifications). Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.

The purpose of this position is to assist in the scale up of manufacturing processes for new DepoFOAM formulations and the development of analytical methods to characterize materials for those efforts. Responsibilities include: Provide technical and analytical assistance to support new product development and process scale-up. Perform hands on work to set-up and execute experiments on bench-top, lab, and pilot scale manufacturing equipment. Support the technology-transfer of processes to the pilot and commercial scales to produce material for pre-clinical evaluation and clinical trials. Execute analytical methods for in-process and product material characterization, performing physical and chemical stability studies as needed. Maintain good working knowledge of the use, maintenance and repair of laboratory and manufacturing equipment.

The Quality Associate II, Document Control follows the applicable Document Control SOPs and requirements in order to maintain a controlled environment within Document Control. This role, which is customer service oriented, works with various departments to either retrieve completed documents or generate new documents. Works in more complex areas of Document Control including APR documents, the Electronic Document Management System (EDMS), and management of documents during regulatory inspections. Provides guidance to the Document Control staff. Trains Quality Associate I, Document Control. Works with the team in maintaining a collaborative environment.

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II/III and Commercial GMP manufacturing. Key responsibilities include but are not limited to: Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase I/II/III/Commercial GMP Manufacturing facility. Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam. Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples. Ability to isolate and sub-culture microorganisms for identification.

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trials) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Daily tasks include: Triage incoming reports for completeness, legibility and validity. Electronic documentation and quality control of drug safety information. Data entry of case reports into safety database / tracking system.

The main functions of a Process Engineer are focused around two key activities of the production area: identifying and mitigating packaging issues for existing business through strong engineering and process improvement methods, and designing and supporting packaging processes for new business. Both activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and facilitation of teams, tracking and analysis metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.

As a Quality Engineer at Penumbra, you will participate in all aspects of product development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. Responsibilities include: Represent Quality Engineering on New Product Development (NPD) cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing. Troubleshoot, update, and improve difficult manufacturing processes for assigned product lines.

The Level 1 Validation Engineer/Specialist works within a small team environment to provide technical services to pharmaceutical or medical device manufacturers.  Technical services may include interpreting drawings, manuals, or other technical information to develop requirement documents, developing testing documents that verify installation, and/or operation of the equipment, and execution /documentation of these testing documents.  These documents are used by our life science customers to demonstrate compliance with USFDA regulations (or other regulatory bodies) for current Good Manufacturing Practices.

Provides comprehensive package engineering support and packaging component expertise to the company through the design, development, and maintenance of packaging standards for various company and outside sub-contracting product packaging sites. Responsibilities include: Troubleshoots and resolves packaging issues associated with packaging component quality, packaging equipment, and packaging line efficiency, participates in packaging component deviation resolutions, and coordinates, conducts, and documents packaging line trials for new or improved packaging components. Works closely with other functional areas and multi-functional teams such as Operations, Sales, Marketing, Procurement, Contract Customers, Contract Packagers, Master Data, Art and Quality to launch new products/packages, develops promotions and displays, develops cost savings initiative, and troubleshoots packaging problems.

Pfenex is looking to bring on a contract Associate Scientist 1 , to join the Analytical Sciences team. As a key member of the Analytical Biochemistry Group, the Associate Scientist I ,is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that manufacturing processes are properly characterized to support process transfer, achieve project goals, and timelines.

(Two openings)These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Responsibilities include: Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging, Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection, Maintains records and documentation associated with producing cartridges in compliance with GMP and SOPs

Duties and functions include: Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures. Investigation and testing of product processes. Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning

We are seeking an experienced individual who has coordinated the implementation of clinical research protocols. 1-3 years of clinical research experience and CCRC certification is preferred for this full-time position.

Essential job functions include: Performs IHC, ELISA, and any other relevant tests as needed to conduct product development testing. Assists with establishing, maintaining, and updating the Design History Files (DHF) for new and/or existing products. Performs published literature reviews. Identifies and documents published clones, published protocols, etc as required.Provides technical support on developing new and improving existing IHC reagent processes and products. Conducts organized development testing to generate support data for new potential products or changes to current products.

Evaluate stable isotope products according to established protocols, provide technical support to others and perform operations in support of the group and department. Essential job functions include: Perform multi-disciplined, established assays and/or unit operations, involving stable isotope compounds. Ensure all applicable log books have been filled out completely as required by current procedures. Perform routine troubleshooting and miscellaneous duties or tasks as necessary. In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles.

Provide support managing the Samples and Marketing Materials for the Mission salesforce teams. Assist with coordinating shipment orders with the Distribution Centers on a weekly basis. Coordinate and maintain items in Sales force Ordering system on daily basis. Maintain the Sales Incentive reward program for the sales force. Provide sales reports for samples and marketing materials to the marketing teams and Outside Marketing Resources, when requested, usually monthly. Provide Sales Reports to Department Supervisor when necessary. Maintain inventory of samples and training materials for the new hire training. On a quarterly basis, pack and ship new hire training materials to and from the training location, as required.

The individual in this role will perform cGMP QC testing for QC Chemistry, release and stability.   Also, this individual may support special projects as assigned. The shift for this role will be a 4 days a week for 10 hours a day (4X10) on either Sunday-Wednesday or Wednesday -Saturday.

This position will be involved in all aspects of studies supporting the bioanalysis of drug molecules in multiple matrices.  The position is hands-on, working in close cooperation with and under the guidance of more senior staff members in a fast-paced environment where a commitment to teamwork, quality data and speed is essential.

A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.

The Research Technician will collect and record data with minimal supervision in the performance of studies.  During a typical day, you can expect to perform clinical observations, sample collection, monitoring of food consumption, animal husbandry, and accurate data collection and reporting, along with the handling and restraint of animals.  Additionally, you will also administer test substances by various basic methods, perform study preparation activities, read basic study protocols and extract pertinent information, review documentation of performed functions, maintain a clean work area, receive animals of all species (general health observation, sexing and identification), and perform all job functions using Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs), processes, and company policies.

Essential duties and responsibilities include: Purification of a wide variety of cardiac muscle proteins using various chromatographic techniques, Carry out multiple experiments in parallel and keep detailed, meticulous notes, Analyze and report experimental results, both in daily updates, regular database inputs, and in final reports, Execute all methods and techniques required to purify soluble and secreted proteins including the ӒKTA PURE FPLC platform, SDS-PAGE, TFF, microfluidizer, plate-based assays, spectrophotometry, and HPLC

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

Clinical Data Entry Operator 1 accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. Primary responsibilities include: Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning, Accession samples with high accuracy and efficiency, Protect patient health information (PHI) at all times to ensure compliance with HIPAA and privacy policies.

We are seeking highly motivated, energetic and committed individuals to join our interdisciplinary team and actively contribute to advancing our drug discovery programs from discovery to proof-of-concept. You will build your experience in early discovery projects using cell-based and biochemical/biophysical approaches to support small-molecule discovery activities and advance our cutting-edge programs that target the mTORC1 pathway

This is a collaborative, team‐based role with the responsibility to perform Molecular Biology and C. elegans screening tasks for R&D discovery and development projects. Responsibilities include: Perform molecular biology assays including PCR, qPCR, and gel electrophoresis. C. elegans culture and maintenance. Working knowledge of basic laboratory equipment and protocols, including solution preparation and dilution series.This is a collaborative, team‐based role with the responsibility to perform Molecular Biology and C. elegans screening tasks for R&D discovery and development projects. Responsibilities include: Perform molecular biology assays including PCR, qPCR, and gel electrophoresis. C. elegans culture and maintenance. Working knowledge of basic laboratory equipment and protocols, including solution preparation and dilution series.

The Diagnostic Production Department for Neogen Corporation is seeking candidates for a technician position responsible for manufacturing, packaging, and assembly of diagnostic test kit components. The ideal candidate will be reliable, possess attention to detail, and able to work in a fast-paced environment. Responsibilities include: Sets up, adjusts, and operates laboratory equipment and instruments including, but not limited to: balances, microplate dispensing equipment, reagent dispensing equipment, bottle cap tightener, and labeling equipment. Cleans and maintains work areas and equipment used in daily manufacturing duties. Produces and packages plates approved by QC Department.

The Food Safety Division is currently seeking a candidate for a Lateral Flow Chemist position. The selected candidate would be responsible for formulating reagents and preparation of some components used in the assembly of Diagnostics and Dairy Antibiotics Lateral Flow products. Other duties would include testing and documenting results following ISO and GMP procedures. The ideal candidate should have the ability to perform basic mathematical operations, follow and document all manufacturing procedures, be capable of identifying and resolving problems in a timely manner and be able to work both independently, as well in a group setting. The selected candidate will be responsible for preparing buffers, solutions, and reagents according to Standard Manufacturing Procedures (SMP’s) and Work Orders, while maintaining an accurate inventory of chemicals and supplies.

Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies / procedures, FDA and cGMP regulations. Ensures the accuracy and completeness of batch records. Monitors and perform start up, in-process and finished product inspections including weighing. Monitor all production areas and personnel for adherence to all cGMP, SOP’s and safety regulations.

Maintain quality standards in and around manufacturing areas, ensuring a safe work environment for all personnel and helps to develop a culture of accountability, continuous improvement, and collaboration. Responsibilities includes: Write, review, and improve manufacturing procedures and forms in compliance with the quality system, ensuring accuracy and consistency. Collaborate with Manufacturing and Development Engineers to create, review, and maintain manufacturing routers. Including verifying manufacturing labor times are properly calculated. Support departmental responsibilities associated with training and qualifying manufacturing assemblers.

Job duties and responsibilities include: support process development of phase appropriate cell therapy production processes. Evaluate raw materials and culture systems for use in cell therapy manufacturing processes. Support process optimization efforts to increase process robustness, reduce costs and improve yield. Design and execute experiments independently; accurately record, analyze and communicate data to senior staff and team members.

Job duties and responsibilities include: Electrical and mechanical aptitude with the ability to design, fabricate and wire electrical control panels and test fixtures. Write comprehensive documentation on tester hardware and software designs. Provide troubleshooting support to engineering and assembly teams on products and processes

Responsible for designing, defining, implementing system requirements, analyzing and/or testing Asymtek products. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.  Receives specific and detailed instructions as to required activities and expected results.  Performs a variety of routine tasks, which should provide experience and familiarization with the engineering staff, methods, practices and programs of the company.

In this role, the incumbent conducts process research, process development and process upscaling for new medical device products. She/He also investigates and evaluates existing technology and designs new methodology, materials, machines and/or processes as needed for medical device development. Responsible for leading, participating in or supporting the product development activities such as prototyping/testing, pilot builds, verification & validation testing, risk assessment and production tooling validation. Generates detailed fabrication drawings, appropriate product requirements and technical file documents and leads design reviews. Responsible for the design and development of mechanical components, systems, and products using PTC Creo

Individual is responsible for ordering lab supplies by inventorying stock; placing orders; verifying receipt, restocking lab and discarding expired reagents. Individual will track critical reagent supplies and notify affected personnel when supplies are low. Individual will maintain laboratory equipment by following standard operating procedures; maintain equipment related supplies, record and maintain equipment temperature logs. Individual will be responsible for performing daily/weekly and monthly equipment (Biosafety cabinets, incubators, water baths, plate washers, refrigerators, freezers etc) cleaning as per laboratory schedule.

The entry level Research Technician will be responsible for supporting study progression according to study protocol and Standard Operating Procedures. Responsible for obtaining vital signs, performing EKGs, and drug/pregnancy testing from study participants as required by the protocol. Observes, obtains and processes all laboratory specimens. Performs service oriented duties along with stocking supplies and general support to all phases of screening process.

The Data Coordinator will be responsible for assisting in the design, implementation and delivery of high quality clinical data within project timelines.  Will execute data queries; perform medical coding, data reconciliation for study databases, and tracks data clarifications.  Assists in the design of study start up documents i.e. Data Management Plan, eCRF, spec design, and edit check specs

We are looking for a Jr.-level applications developer to design, build, modify, deploy, and support custom applications to complement existing syndicated applications per our client’s needs.

A Scientist will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.

The successful applicant will work with internal functional groups to help design and execute screening strategies for therapeutic antibody discovery campaigns – including biochemical, molecular, and/or cellular assays for the testing of biotherapeutics from discovery to lead-optimization. Work with internal functional groups to develop, optimize and execute high throughput binding assays (ELISA, Octet, FACS) and cell-based assays (functional, phenotypic, reporter etc.) for screening panels of therapeutic antibody candidates

Prepares laboratory specimens for analysis and testing. Spinning samples, pouring urine tubes and creating frozen samples. Picking up and delivering samples to clients/hospitals. Unpacks and routes specimens to their respective staging areas. Accurately Identify and label specimens. Pack and ship specimens to proper testing facilities.

Prepares laboratory specimens for designated departments/locations prior to laboratory analysis and testing. Unpacks specimens from branches or ports and routes specimens by type to various staging areas. Prepares all specimens received for testing in designated laboratory departments or locations such as staging of specimens, centrifuge, separate serum, and blood smears. Aliquots sample for departments. Prepares excess specimen samples for storage and resolves and document problem specimens.

Responsibilities include but are not limited to: Maintain laboratory instruments, follow SOPs for mammalian cell culture and protein/antibody purification, conduct data input, analysis, and interpretation, think critically and creatively to determine appropriate resources for resolution of problems, recognize and trouble shoot anomalous and inconsistent experimental results.

Seeking a highly motivated Research Associate I/II with a background in Molecular Biology to assist in the development of new technologies including CRISPR genome engineering and recombinant antibody generation. The successful candidate will be responsible for learning, researching and implementing recombinant DNA approaches to support research team needs, as well as designing work-flows, and assay development.

We are seeking a Research Assistant with expertise in the use of molecular biology tools such as RNA/DNA extraction, PCR/qPCR, RT-qPCR, plasmid miniprep, and DNA restriction and electrophoresis. Experience in molecular cloning (traditional and seamless aka Gibson), designing constructs, analyzing sequencing data etc. Role will likely evolve to support our effort to engineer and manipulate fungal secondary metabolite clusters to increase the titers of natural product production and establish LifeMine’s fungal genomically-enabled drug discovery platform.